Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Pati... | NCT00183820

NCT00183820

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
paclitaxel, gemcitabine, and oxaliplatin	Experimental		Drug: paclitaxel, gemcitabine, and oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
paclitaxel, gemcitabine, and oxaliplatin	Drug	Paclitaxel 170 mg/m2 IV d 1 14 days Gemcitabine 800 mg/m2 IV d 1 14 days Oxaliplatin 100 mg/m2 IV d 1 14 days	paclitaxel, gemcitabine, and oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor Response	Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.	From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival	Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.	Through study completion, about 9 years
Overall Survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
Must have refractory germ cell neoplasm defined as one or more of the following:
- patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP
Must have one or more of the following (check all that apply):
- unidimensionally measurable doze assessed within 14 days prior to registration,
- elevated β-HCG > 20 mIU assessed within 24-48 hours prior to registration, OR
- AFP > 2 x uln assessed within 5-7 days prior to registration
Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.
X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects
Zubrod PS less than or equal to 2
Greater than or equal to 16 years of age
AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days prior to registration)
LDH (obtained within 7 days prior to registration)
Creatinine < 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
Men of reproductive potential must agree to use effective contraceptive method
Signed informed consent (including HIPAA authorization)

Exclusion Criteria:

Prior tx with cytotoxic or experimental agents within 14 days prior to registration
Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these values can be ascribed to another tumor-related phenomena)
Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years

Name	Affiliation	Role
David Quinn, MD	University of Southern California	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States

ID	Title	Description
FG000	Paclitaxel, Gemcitabine, and Oxaliplatin	paclitaxel, gemcitabine, and oxaliplatin: Paclitaxel 170 mg/m2 IV d 1 14 days Gemcitabine 800 mg/m2 IV d 1 14 days Oxaliplatin 100 mg/m2 IV d 1 14 days

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Paclitaxel, Gemcitabine, and Oxaliplatin	paclitaxel, gemcitabine, and oxaliplatin: Paclitaxel 170 mg/m2 IV d 1 14 days Gemcitabine 800 mg/m2 IV d 1 14 days Oxaliplatin 100 mg/m2 IV d 1 14 days

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

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

Tumor Response

Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.

1 patient was inevaluable.

Posted

Count of Participants

Participants

From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years

ID	Title	Description
OG000

Adverse Events Module

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	Paclitaxel, Gemcitabine, and Oxaliplatin	paclitaxel, gemcitabine, and oxaliplatin: Paclitaxel 170 mg/m2 IV d 1 14 days Gemcitabine 800 mg/m2 IV d 1 14 days Oxaliplatin 100 mg/m2 IV d 1 14 days

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Allergic reaction/hypersensitivity (including drug fever)	General disorders	CTCAE (3.0)	Systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Allergic reaction/hypersensitivity (including drug fever)	General disorders	CTCAE (3.0)	Systematic Assessment

ID	Term
D013736	Testicular Neoplasms
D009373	Neoplasms, Germ Cell and Embryonal

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005834	Genital Neoplasms, Male

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic