PACCE: Panitumumab Advanced Colorectal Cancer Evaluation... | NCT00115765

NCT00115765

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxaliplatin and bevacizumab without panitumumab	Active Comparator	Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone.	Drug: Oxaliplatin Based Chemotherapy Drug: Bevacizumab
Irinotecan and bevacizumab plus panitumumab	Experimental	Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W	Drug: Panitumumab Drug: Irinotecan Based Chemotherapy Drug: Bevacizumab
Irinotecan and bevacizumab without panitumumab	Active Comparator	Irinotecan-based chemotherapy and Bevacizumab Q2W alone	Drug: Irinotecan Based Chemotherapy Drug: Bevacizumab
Oxaliplatin and bevacizumab plus panitumumab	Experimental	Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W	Drug: Oxaliplatin Based Chemotherapy Drug: Panitumumab Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin Based Chemotherapy	Drug	Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (Oxaliplatin)	Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression	Overall study
Objective Tumor Response Through Week 12 (Irinotecan)	Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum	Overall Study

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (Oxaliplatin)	Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin	Overall study
Objective Tumor Response Rate (Oxaliplatin)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adenocarcinoma of the colon or rectum
Metastatic colorectal cancer (mCRC)
Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria
ECOG performance status of 0 or 1
Available paraffin-embedded tumor tissue (from primary tumor or metastasis) or unstained slides of paraffin-embedded tissue
If history of other primary cancer, subject will be eligible only if she or he has:
- Curatively resected non-melanomatous skin cancer;
- Curatively treated cervical carcinoma in situ;
- Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 5 years.
Adequate hematologic data as follows:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 cells/L;
- Platelet count greater than or equal to 100 x 10^9/L;
- Hemoglobin greater than or equal to 9.0 g/dL. - Adequate renal function:
- Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN);
- Urinary protein dipstick of less than 2+ (if urinary dipstick 2+ or greater, then excretion of less than or equal to 1000 mg of protein per day as determined by 24-hour urine collection).
Adequate hepatic function:
- Alkaline phosphatase less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)(AST) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Alanine aminotransferase (serum glutamic-pyruvic transaminase) (ALT) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Bilirubin less than or equal to 2 x ULN. - Competent to comprehend, sign, and date an IRB-approved informed consent form
Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
Major surgery within 28 days before randomization
Central nervous system metastases
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
Clinically significant ascites
Preexisting bleeding diathesis or coagulopathy or the need for full-dose anticoagulation
Any of the following within 1 year before randomization:
- Myocardial infarction;
- Unstable angina;
- Symptomatic congestive heart failure;
- Serious uncontrolled cardiac arrhythmia;
- Cerebrovascular accident or transient ischemic attack;
- Gastrointestinal ulcer or hemorrhage;
- Hemoptysis;
- Pulmonary embolism;
- Deep vein thrombosis, or other significant thromboembolic event.
Regular use of non-steroidal anti-inflammatory agents
Female subject of childbearing potential, not abstinent, and not willing to use contraceptives during the course of the study and for 6 months following the last dose of first-line treatment
Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
Male subject, not abstinent, and not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of first-line treatment
Subject known to be human immunodeficiency virus (HIV) positive
Subject allergic to panitumumab or any components of panitumumab formulation
History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
Subject unwilling or unable to comply with study requirements
Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19114685	Background	Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):672-80. doi: 10.1200/JCO.2008.19.8135. Epub 2008 Dec 29.
31378656

Label	URL
FDA-approved Drug Labeling	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Irinotecan and Bevacizumab Without Panitumumab	Irinotecan-based chemotherapy and Bevacizumab Q2W alone
FG001	Oxaliplatin and Bevacizumab Plus Panitumumab	Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
FG002	Oxaliplatin and Bevacizumab Without Panitumumab	Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
FG003	Irinotecan and Bevacizumab Plus Panitumumab	Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000115 subjects FG001413 subjects FG002410 subjects FG003115 subjects
COMPLETED		FG00080 subjectsParticipants who were on study at closure or died FG001313 subjectsParticipants who were on study at closure or died FG002289 subjectsParticipants who were on study at closure or died FG003
NOT COMPLETED		FG00035 subjects FG001100 subjects FG002121 subjects FG00331 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG00022 subjects FG00153 subjects FG00276 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Oxaliplatin and Bevacizumab Without Panitumumab	Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
BG001	Irinotecan and Bevacizumab Plus Panitumumab	Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W

Units	Counts
Participants	BG000

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

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

Progression-Free Survival (Oxaliplatin)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

Intention-to-Treat

Posted

Median

95% Confidence Interval

Month

Overall study

ID	Title	Description
OG000	Oxaliplatin and Bevacizumab Plus Panitumumab	Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
OG001	Oxaliplatin and Bevacizumab Without Panitumumab	Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone

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	Panit. Plus Bevacizumab With Chemotherapy

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Study Director	Amgen Inc.	866-572-6436

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D015179	Colorectal Neoplasms
D012004	Rectal Neoplasms
D009369	Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Intervention Browse Module

ID	Term
D000077150	Oxaliplatin
D000077544	Panitumumab
C480833	IFL protocol
D000068258	Bevacizumab

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal

Masking Info

Best overall response of complete or partial response within oxaliplatin stratum

Participants who were on study at closure or died

Units	Counts
Participants	OG000413 OG001410

EG0000 affected518 at risk

EG0014 affected510 at risk

EG000177 affected518 at risk

EG001147 affected510 at risk