An Ovarian, Primary Peritoneal or Fallopian Tube Cancer S... | NCT00191646 | Trialant
NCT00191646
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 4, 2011Estimated
Enrollment
919Actual
Phase
Phase 3
Conditions
Genital Neoplasms, Female
Fallopian Tube Neoplasms
Ovarian Neoplasms
Pelvic Neoplasms
Peritoneal Neoplasms
Interventions
Gemcitabine
Paclitaxel
Carboplatin
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT00191646
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6891
Secondary IDs
ID
Type
Description
Link
B9E-US-S302
Other Identifier
Eli Lilly and Company
Brief Title
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
Official Title
Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian, Primary Peritoneal Cancer or Fallopian Tube Carcinoma
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Feb 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2002
Primary Completion Date
Aug 2009Actual
Completion Date
Aug 2009Actual
First Submitted Date
Sep 12, 2005
First Submission Date that Met QC Criteria
Sep 12, 2005
First Posted Date
Sep 19, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 12, 2010
Results First Submitted that Met QC Criteria
Aug 12, 2010
Results First Posted Date
Sep 9, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 28, 2011
Last Update Posted Date
Mar 4, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.
Detailed Description
This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.
Conditions Module
Conditions
Genital Neoplasms, Female
Fallopian Tube Neoplasms
Ovarian Neoplasms
Pelvic Neoplasms
Peritoneal Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
919Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Gemcitabine/Carboplatin
Experimental
Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles
Drug: Gemcitabine
Drug: Carboplatin
Paclitaxel/Carboplatin
Active Comparator
Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
Drug: Paclitaxel
Drug: Carboplatin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Gemcitabine
Drug
1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles
If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS)
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Baseline to measured progressive disease or death up to 82 months
Secondary Outcomes
Measure
Description
Time Frame
Proportion of Participants With Response (Response Rate)
Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
Patients must be enrolled no more than twelve weeks postoperatively.
Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.
Key Exclusion Criteria:
Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix
Arizona
85006
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
919 patients were randomized, only 831 randomized patients were included in any analyses. 85 randomized patients were excluded due to significant noncompliant issues and 3 patients were excluded due to unavailable data.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Gemcitabine/Carboplatin
LY188011
Gemzar
Paclitaxel
Drug
175 mg/m^2, IV, Day 1, q 21 days x 6 cycles
If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year)
If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity
Paclitaxel/Carboplatin
Carboplatin
Drug
Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles
Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles
Gemcitabine/Carboplatin
Paclitaxel/Carboplatin
Baseline to measured progressive disease up to 82 months
Time to Treatment Failure
Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Baseline to stopping treatment up to 82 months
Overall Survival
Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Baseline to death from any cause up to 82 months
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock
Arkansas
72205
United States
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Los Gatos
California
95032
United States
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Modesto
California
95350
United States
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San Diego
California
92121
United States
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Englewood
Colorado
80113
United States
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Newark
Delaware
19713
United States
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Fort Myers
Florida
33901
United States
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South Miami
Florida
33143
United States
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Sunrise
Florida
33323
United States
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Atlanta
Georgia
30342
United States
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Savannah
Georgia
31404
United States
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Palatine
Illinois
60067
United States
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Indianapolis
Indiana
46260
United States
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South Bend
Indiana
46617
United States
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Metairie
Louisiana
70006
United States
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New Orleans
Louisiana
70121
United States
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Scarborough
Maine
04074
United States
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Detroit
Michigan
48201
United States
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Grand Rapids
Michigan
49546
United States
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Duluth
Minnesota
55805
United States
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Minneapolis
Minnesota
55455
United States
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Rochester
Minnesota
55905
United States
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Kansas City
Missouri
64111
United States
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St Louis
Missouri
63141
United States
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Billings
Montana
59107
United States
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Las Vegas
Nevada
89109
United States
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Reno
Nevada
89502
United States
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Hackensack
New Jersey
07601
United States
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Rochester
New York
14620
United States
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Chapel Hill
North Carolina
27599
United States
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Charlotte
North Carolina
28204
United States
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Durham
North Carolina
27710
United States
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Greenville
North Carolina
27858
United States
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Columbus
Ohio
43222
United States
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Dayton
Ohio
45429
United States
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Oklahoma City
Oklahoma
73112
United States
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Dunmore
Pennsylvania
18512
United States
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Johnstown
Pennsylvania
15905
United States
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Pittsburgh
Pennsylvania
15224
United States
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Sayre
Pennsylvania
18840
United States
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Providence
Rhode Island
02905
United States
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Charleston
South Carolina
29425
United States
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Columbia
South Carolina
29210
United States
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Greenville
South Carolina
29601
United States
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Chattanooga
Tennessee
37404
United States
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Knoxville
Tennessee
37920
United States
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Memphis
Tennessee
38120
United States
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Austin
Texas
78735
United States
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Lubbock
Texas
79410
United States
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Salt Lake City
Utah
84106
United States
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Roanoke
Virginia
24014
United States
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Seattle
Washington
98104
United States
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Madison
Wisconsin
53792
United States
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San Juan
009362712
Puerto Rico
FG001
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days.
FG000417 subjects
FG001414 subjects
Received Induction Therapy
FG000411 subjects
FG001409 subjects
Received Consolidation Therapy
FG000169 subjects
FG001183 subjects
Received Crossover Therapy
FG00077 subjects
FG00178 subjects
COMPLETED
FG000246 subjectsCompleted was defined as the patients treated in either consolidation therapy or crossover therapy.
FG001261 subjectsCompleted was defined as the patients treated in either consolidation therapy or crossover therapy.
NOT COMPLETED
FG000171 subjects
FG001153 subjects
Type
Comment
Reasons
Toxicity
FG00026 subjects
FG00137 subjects
Disease Progression
FG0005 subjects
FG0016 subjects
Physician Decision
FG00020 subjects
FG00111 subjects
Withdrawal by Subject
FG00058 subjects
FG00139 subjects
Protocol Violation
FG0005 subjects
FG0017 subjects
Death
FG0006 subjects
FG0018 subjects
Other
FG00033 subjects
FG00134 subjects
Missing Data
FG00018 subjects
FG00111 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days.
BG001
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000417
BG001414
BG002831
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.7± 11.4
BG00160.3± 10.8
BG00260.0± 11.1
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000417
BG001414
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG000379
BG001379
BG002
Organ of Origin
Organ from which disease originated
Number
participants
Title
Denominators
Categories
Ovary
Title
Measurements
BG000355
BG001362
BG002
Extent of Residual Disease
Patients either had no clinical evidence of residual disease (non-measurable), either by physical or radiologic exam, that was measurable as defined below or they had residual disease that was measured by either of the following techniques. Measurable lesions were those which could be measured accurately and followed in at least one dimension (the longest dimension being the one recorded). Each lesion must be >= 20 millimeters (mm) when measured by conventional techniques [palpation, plain X-ray, Computed tomography (CT), and Magnetic resonance imaging (MRI)], or >= 10 mm by spiral CT.
Number
participants
Title
Denominators
Categories
Measurable
Title
Measurements
BG000139
BG001
Zubrod Performance Status
0 Asymptomatic
Symptomatic, fully ambulatory
Symptomatic, in bed < 50% of the day
Symptomatic, in bed > 50% of the day but not bedridden
Bedridden
Dead
Number
participants
Title
Denominators
Categories
0
Title
Measurements
BG000239
BG001232
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Ic: Tumor is either Stage IA or IB level but the capsule is ruptured or there is tumor on the ovarian surface or malignant cells are present in ascites or washings.
II: Tumor involves one or both ovaries with pelvic extension
III: Tumor involving one or both ovaries, with microscopically confirmed peritoneal metastases outside the pelvis and/or regional lymph node metastases
Volume of Residual Tumor Following Debulking Surgery
Number
participants
Title
Denominators
Categories
< 2 centimeters
Title
Measurements
BG000309
BG001314
BG002
CA-125 Units per milliliter at Baseline for All Patients
Cancer Antigen 125, units per milliliter
Mean
Standard Deviation
units per milliliter
Title
Denominators
Categories
Title
Measurements
BG000492.772± 1138.556
BG001479.854± 1117.040
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Progression Free Survival (PFS)
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.
Posted
Median
95% Confidence Interval
Months
Baseline to measured progressive disease or death up to 82 months
ID
Title
Description
OG000
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days.
OG001
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days.
Units
Counts
Participants
OG000414
OG001413
Title
Denominators
Categories
Title
Measurements
OG00020.0(17.9 to 22.2)
OG00122.2(19.0 to 25.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.
Log Rank
0.199
95
No
Superiority or Other
Secondary
Proportion of Participants With Response (Response Rate)
Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).
All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.
Posted
Mean
95% Confidence Interval
proportion of responders
Baseline to measured progressive disease up to 82 months
ID
Title
Description
OG000
Gemcitabine/Carboplatin (Induction)
Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
OG001
Paclitaxel/Carboplatin (Induction)
Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
Secondary
Time to Treatment Failure
Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.
Posted
Median
95% Confidence Interval
months
Baseline to stopping treatment up to 82 months
ID
Title
Description
OG000
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days.
OG001
Paclitaxel/Carboplatin
Secondary
Overall Survival
Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.
Posted
Median
95% Confidence Interval
months
Baseline to death from any cause up to 82 months
ID
Title
Description
OG000
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days.
OG001
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days.
Time Frame
Not provided
Description
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Gemcitabine/Carboplatin Induction
Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
96
412
404
412
EG001
Paclitaxel/Carboplatin Induction
Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
72
408
394
408
EG002
Consolidation (Gemcitabine to Paclitaxel)
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
14
169
157
169
EG003
Consolidation (Paclitaxel to Paclitaxel)
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
12
183
170
183
EG004
Crossover (Paclitaxel to Gemcitabine)
Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
8
78
76
78
EG005
Crossover (Gemcitabine to Paclitaxel)
Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0012 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hypoglycaemic coma
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Syncope
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0010 events0 affected408 at risk
EG0021 events1 affected169 at risk
EG003
Hematologic
Investigations
Systematic Assessment
The adverse event term and organ system were not coded via MedDRA. The organ system was provide as a requirement to release the record.
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Infection/febrile neutropenia
Infections and infestations
Systematic Assessment
The adverse event term and organ system were not coded via MedDRA. The organ system was provide as a requirement to release the record.
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Costovertebral angle tenderness
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0013 events3 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Renal infarct
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Vaginal fistula
Reproductive system and breast disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0013 events2 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0003 events3 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0012 events2 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0004 events3 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0015 events5 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Respiratory depression
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG0002 events2 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0013 events3 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pain management
Surgical and medical procedures
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0006 events6 affected412 at risk
EG0013 events3 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0001 events1 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hypotension
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0010 events0 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0000 events0 affected412 at risk
EG0011 events1 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA 10.0
Systematic Assessment
EG00025 events9 affected412 at risk
EG00125 events10 affected408 at risk
EG0024 events2 affected169 at risk
EG0039 events4 affected183 at risk
EG00410 events4 affected78 at risk
EG0051 events1 affected77 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 10.0
Systematic Assessment
EG00068 events22 affected412 at risk
EG00112 events8 affected408 at risk
EG0024 events1 affected169 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 10.0
Systematic Assessment
EG00031 events18 affected412 at risk
EG00139 events22 affected408 at risk
EG00226 events8 affected169 at risk
EG003
Vision blurred
Eye disorders
MedDRA 10.0
Systematic Assessment
EG00026 events15 affected412 at risk
EG00150 events26 affected408 at risk
EG00226 events9 affected169 at risk
EG003
Visual disturbance
Eye disorders
MedDRA 10.0
Systematic Assessment
EG0005 events5 affected412 at risk
EG00115 events11 affected408 at risk
EG00215 events8 affected169 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG00032 events21 affected412 at risk
EG00116 events11 affected408 at risk
EG00224 events9 affected169 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG000168 events88 affected412 at risk
EG001148 events92 affected408 at risk
EG00276 events29 affected169 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG00027 events21 affected412 at risk
EG00124 events16 affected408 at risk
EG00213 events8 affected169 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG000400 events173 affected412 at risk
EG001391 events170 affected408 at risk
EG002154 events54 affected169 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG000145 events83 affected412 at risk
EG001187 events97 affected408 at risk
EG002107 events43 affected169 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG00021 events16 affected412 at risk
EG00126 events17 affected408 at risk
EG00224 events9 affected169 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG000504 events213 affected412 at risk
EG001506 events205 affected408 at risk
EG002191 events67 affected169 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG00033 events25 affected412 at risk
EG00140 events23 affected408 at risk
EG00218 events11 affected169 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 10.0
Systematic Assessment
EG000146 events95 affected412 at risk
EG001154 events95 affected408 at risk
EG00224 events19 affected169 at risk
EG003
Asthenia
General disorders
MedDRA 10.0
Systematic Assessment
EG00039 events28 affected412 at risk
EG00141 events34 affected408 at risk
EG00212 events7 affected169 at risk
EG003
Fatigue
General disorders
MedDRA 10.0
Systematic Assessment
EG000948 events281 affected412 at risk
EG001912 events279 affected408 at risk
EG002531 events108 affected169 at risk
EG003
Oedema
General disorders
MedDRA 10.0
Systematic Assessment
EG00031 events20 affected412 at risk
EG00113 events8 affected408 at risk
EG0025 events3 affected169 at risk
EG003
Oedema peripheral
General disorders
MedDRA 10.0
Systematic Assessment
EG00084 events46 affected412 at risk
EG00153 events33 affected408 at risk
EG00250 events18 affected169 at risk
EG003
Pain
General disorders
MedDRA 10.0
Systematic Assessment
EG00031 events25 affected412 at risk
EG00159 events38 affected408 at risk
EG00276 events36 affected169 at risk
EG003
Pyrexia
General disorders
MedDRA 10.0
Systematic Assessment
EG00047 events34 affected412 at risk
EG00124 events19 affected408 at risk
EG0024 events4 affected169 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 10.0
Systematic Assessment
EG0005 events5 affected412 at risk
EG0017 events5 affected408 at risk
EG0027 events5 affected169 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 10.0
Systematic Assessment
EG0006 events6 affected412 at risk
EG00118 events13 affected408 at risk
EG0023 events3 affected169 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 10.0
Systematic Assessment
EG00012 events12 affected412 at risk
EG0018 events6 affected408 at risk
EG00210 events7 affected169 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 10.0
Systematic Assessment
EG00031 events28 affected412 at risk
EG00141 events31 affected408 at risk
EG00215 events10 affected169 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 10.0
Systematic Assessment
EG00048 events31 affected412 at risk
EG00128 events15 affected408 at risk
EG00212 events9 affected169 at risk
EG003
Alanine aminotransferase
Investigations
MedDRA 10.0
Systematic Assessment
EG00053 events24 affected412 at risk
EG00133 events19 affected408 at risk
EG0026 events4 affected169 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 10.0
Systematic Assessment
EG000120 events64 affected412 at risk
EG00146 events27 affected408 at risk
EG00227 events10 affected169 at risk
EG003
Anc/agc
Investigations
MedDRA 10.0
Systematic Assessment
EG0001,638 events378 affected412 at risk
EG0011,531 events361 affected408 at risk
EG002314 events88 affected169 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 10.0
Systematic Assessment
EG000100 events58 affected412 at risk
EG00136 events21 affected408 at risk
EG00221 events10 affected169 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 10.0
Systematic Assessment
EG00039 events18 affected412 at risk
EG00136 events17 affected408 at risk
EG0022 events2 affected169 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA 10.0
Systematic Assessment
EG00051 events23 affected412 at risk
EG00132 events20 affected408 at risk
EG00219 events6 affected169 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 10.0
Systematic Assessment
EG000103 events52 affected412 at risk
EG00168 events37 affected408 at risk
EG00233 events13 affected169 at risk
EG003
Blood glucose
Investigations
MedDRA 10.0
Systematic Assessment
EG00018 events11 affected412 at risk
EG00132 events22 affected408 at risk
EG00217 events12 affected169 at risk
EG003
Blood glucose increased
Investigations
MedDRA 10.0
Systematic Assessment
EG00093 events46 affected412 at risk
EG001108 events50 affected408 at risk
EG00279 events26 affected169 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 10.0
Systematic Assessment
EG00028 events14 affected412 at risk
EG00141 events23 affected408 at risk
EG0027 events5 affected169 at risk
EG003
Blood urea increased
Investigations
MedDRA 10.0
Systematic Assessment
EG00039 events19 affected412 at risk
EG00128 events18 affected408 at risk
EG00253 events22 affected169 at risk
EG003
Carbon dioxide increased
Investigations
MedDRA 10.0
Systematic Assessment
EG00041 events18 affected412 at risk
EG00111 events8 affected408 at risk
EG00233 events12 affected169 at risk
EG003
Haematocrit
Investigations
MedDRA 10.0
Systematic Assessment
EG00042 events24 affected412 at risk
EG00133 events17 affected408 at risk
EG0023 events1 affected169 at risk
EG003
Hemoglobin
Investigations
MedDRA 10.0
Systematic Assessment
EG0001,830 events385 affected412 at risk
EG0011,436 events352 affected408 at risk
EG002338 events83 affected169 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 10.0
Systematic Assessment
EG0008 events5 affected412 at risk
EG0011 events1 affected408 at risk
EG0029 events6 affected169 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 10.0
Systematic Assessment
EG00019 events16 affected412 at risk
EG00113 events9 affected408 at risk
EG00212 events2 affected169 at risk
EG003
Platelets
Investigations
MedDRA 10.0
Systematic Assessment
EG0001,550 events379 affected412 at risk
EG001631 events233 affected408 at risk
EG002110 events36 affected169 at risk
EG003
Protein total decreased
Investigations
MedDRA 10.0
Systematic Assessment
EG00010 events9 affected412 at risk
EG00120 events15 affected408 at risk
EG00217 events7 affected169 at risk
EG003
White blood cells
Investigations
MedDRA 10.0
Systematic Assessment
EG0001,714 events380 affected412 at risk
EG0011,507 events350 affected408 at risk
EG002423 events88 affected169 at risk
EG003
Weight decreased
Investigations
MedDRA 10.0
Systematic Assessment
EG00067 events37 affected412 at risk
EG00145 events31 affected408 at risk
EG00210 events6 affected169 at risk
EG003
Weight increased
Investigations
MedDRA 10.0
Systematic Assessment
EG00060 events24 affected412 at risk
EG00133 events15 affected408 at risk
EG002100 events26 affected169 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG00082 events49 affected412 at risk
EG00199 events57 affected408 at risk
EG00222 events13 affected169 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG000111 events45 affected412 at risk
EG001158 events72 affected408 at risk
EG002150 events36 affected169 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG00035 events17 affected412 at risk
EG00118 events11 affected408 at risk
EG0020 events0 affected169 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG00029 events14 affected412 at risk
EG00112 events8 affected408 at risk
EG0022 events2 affected169 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG00047 events29 affected412 at risk
EG00129 events20 affected408 at risk
EG00213 events6 affected169 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 10.0
Systematic Assessment
EG00019 events14 affected412 at risk
EG00124 events14 affected408 at risk
EG0029 events6 affected169 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00086 events48 affected412 at risk
EG001247 events108 affected408 at risk
EG002192 events66 affected169 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00016 events8 affected412 at risk
EG0016 events4 affected408 at risk
EG00210 events4 affected169 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00072 events47 affected412 at risk
EG00181 events42 affected408 at risk
EG00237 events19 affected169 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00022 events14 affected412 at risk
EG00145 events33 affected408 at risk
EG00238 events16 affected169 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00030 events15 affected412 at risk
EG00146 events26 affected408 at risk
EG00222 events8 affected169 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00041 events25 affected412 at risk
EG00197 events55 affected408 at risk
EG00291 events37 affected169 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00062 events36 affected412 at risk
EG001220 events100 affected408 at risk
EG002130 events44 affected169 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 10.0
Systematic Assessment
EG00045 events27 affected412 at risk
EG00175 events49 affected408 at risk
EG00245 events18 affected169 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00065 events44 affected412 at risk
EG00152 events34 affected408 at risk
EG00222 events11 affected169 at risk
EG003
Headache
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00082 events40 affected412 at risk
EG00175 events39 affected408 at risk
EG00241 events20 affected169 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00036 events25 affected412 at risk
EG00193 events53 affected408 at risk
EG00270 events29 affected169 at risk
EG003
Neuropathy
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00028 events15 affected412 at risk
EG001140 events65 affected408 at risk
EG002122 events39 affected169 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00058 events22 affected412 at risk
EG001190 events99 affected408 at risk
EG002207 events62 affected169 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00042 events28 affected412 at risk
EG001191 events88 affected408 at risk
EG00294 events38 affected169 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 10.0
Systematic Assessment
EG00042 events20 affected412 at risk
EG001162 events61 affected408 at risk
EG00291 events26 affected169 at risk
EG003
Neurology
Nervous system disorders
Systematic Assessment
The adverse event term and organ system were not coded via MedDRA. The organ system was provide as a requirement to release the record.
EG0002 events2 affected412 at risk
EG00117 events10 affected408 at risk
EG0024 events3 affected169 at risk
EG003
Pain
Nervous system disorders
Systematic Assessment
The adverse event term and organ system were not coded via MedDRA. The organ system was provide as a requirement to release the record.
EG0007 events6 affected412 at risk
EG0019 events7 affected408 at risk
EG0021 events1 affected169 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 10.0
Systematic Assessment
EG00063 events32 affected412 at risk
EG00150 events35 affected408 at risk
EG00238 events19 affected169 at risk
EG003
Depression
Psychiatric disorders
MedDRA 10.0
Systematic Assessment
EG00092 events47 affected412 at risk
EG001100 events50 affected408 at risk
EG00275 events27 affected169 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 10.0
Systematic Assessment
EG00092 events42 affected412 at risk
EG001150 events73 affected408 at risk
EG00299 events32 affected169 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG00025 events19 affected412 at risk
EG00126 events21 affected408 at risk
EG0027 events6 affected169 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG00032 events18 affected412 at risk
EG00138 events22 affected408 at risk
EG0029 events7 affected169 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG0006 events3 affected412 at risk
EG00112 events8 affected408 at risk
EG00213 events4 affected169 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 10.0
Systematic Assessment
EG00013 events7 affected412 at risk
EG00146 events22 affected408 at risk
EG00220 events9 affected169 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG00057 events37 affected412 at risk
EG00145 events29 affected408 at risk
EG00249 events22 affected169 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG00083 events50 affected412 at risk
EG00199 events67 affected408 at risk
EG00240 events19 affected169 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG00055 events31 affected412 at risk
EG00127 events20 affected408 at risk
EG00220 events9 affected169 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Systematic Assessment
EG00053 events37 affected412 at risk
EG00122 events13 affected408 at risk
EG0026 events5 affected169 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG000260 events94 affected412 at risk
EG001917 events249 affected408 at risk
EG002600 events102 affected169 at risk
EG003
Hypotrichosis
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG00073 events24 affected412 at risk
EG00112 events9 affected408 at risk
EG0022 events2 affected169 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG00032 events18 affected412 at risk
EG00133 events20 affected408 at risk
EG00218 events10 affected169 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 10.0
Systematic Assessment
EG00059 events42 affected412 at risk
EG00168 events42 affected408 at risk
EG00250 events30 affected169 at risk
EG003
Flushing
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG0009 events6 affected412 at risk
EG00122 events11 affected408 at risk
EG00214 events10 affected169 at risk
EG003
Hot flush
Vascular disorders
MedDRA 10.0
Systematic Assessment
EG00099 events38 affected412 at risk
EG001145 events60 affected408 at risk
EG002132 events35 affected169 at risk
EG003
Trial was designed with overall survival as primary endpoint. Enrollment was slower than expected. After 4 years, 919 patients were randomized and in August 2006, protocol was amended: primary endpoint was changed to progression free survival (PFS).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D005833
Genital Neoplasms, Female
D005185
Fallopian Tube Neoplasms
D010051
Ovarian Neoplasms
D010386
Pelvic Neoplasms
D010534
Peritoneal Neoplasms
Ancestor Terms
ID
Term
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D005184
Fallopian Tube Diseases
D000291
Adnexal Diseases
D004701
Endocrine Gland Neoplasms
D010049
Ovarian Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D000008
Abdominal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D010532
Peritoneal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000093542
Gemcitabine
D017239
Paclitaxel
D016190
Carboplatin
Ancestor Terms
ID
Term
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D056831
Coordination Complexes
Browse Leaves
Not provided
Browse Branches
Not provided
831
Male
BG0000
BG0010
BG0020
758
Black or African American
Title
Measurements
BG00012
BG00113
BG00225
Asian
Title
Measurements
BG0005
BG0015
BG00210
Native American
Title
Measurements
BG0002
BG0011
BG0023
Other
Title
Measurements
BG00019
BG00116
BG00235
717
Peritoneum
Title
Measurements
BG00056
BG00150
BG002106
Missing Data
Title
Measurements
BG0006
BG0012
BG0028
114
BG002253
Non-measurable
Title
Measurements
BG000276
BG001300
BG002576
Missing Data
Title
Measurements
BG0002
BG0010
BG0022
BG002471
1
Title
Measurements
BG000139
BG001157
BG002296
2
Title
Measurements
BG00027
BG00116
BG00243
>= 3
Title
Measurements
BG0000
BG0010
BG0020
Missing Data
Title
Measurements
BG00012
BG0019
BG00221
22
BG00243
Stage II
Title
Measurements
BG00044
BG00139
BG00283
Stage III
Title
Measurements
BG000284
BG001289
BG002573
Stage IV
Title
Measurements
BG00068
BG00163
BG002131
Missing Data
Title
Measurements
BG0000
BG0011
BG0021
20
Serous
Title
Measurements
BG000283
BG001276
BG002559
Endometroid
Title
Measurements
BG00044
BG00140
BG00284
Undifferentiated
Title
Measurements
BG0007
BG0017
BG00214
Clear Cell
Title
Measurements
BG00021
BG00123
BG00244
Mixed Epithelial
Title
Measurements
BG0009
BG00113
BG00222
Transitional Cell
Title
Measurements
BG0003
BG0011
BG0024
Malignant Brenner's Tumor
Title
Measurements
BG0000
BG0010
BG0020
Adenocarcinoma Not Otherwise Specified (NOS)
Title
Measurements
BG00022
BG00123
BG00245
Other
Title
Measurements
BG00017
BG00121
BG00238
Missing Data
Title
Measurements
BG0001
BG0010
BG0021
623
>= 2 centimeters
Title
Measurements
BG000102
BG00196
BG002198
Missing Data
Title
Measurements
BG0006
BG0014
BG00210
BG002486.329± 1127.213
OG002
Gemcitabine (Crossover)
Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
OG003
Paclitaxel (Crossover)
Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
Units
Counts
Participants
OG000139
OG001114
OG00228
OG00333
Title
Denominators
Categories
Title
Measurements
OG0000.676(0.638 to 0.798)
OG0010.711(0.651 to 0.822)
OG0020.357(0.194 to 0.576)
OG0030.303(0.161 to 0.500)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.771
95
No
Superiority or Other
OG002
OG003
Fisher Exact
0.784
95
No
Superiority or Other
Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days.