Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-11-01

Brief Summary

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The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panitumumab Plus FOLFIRI

Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.

FOLFIRI

Intervention Type DRUG

FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

FOLFIRI Alone

Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.

Group Type ACTIVE_COMPARATOR

FOLFIRI

Intervention Type DRUG

FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

Interventions

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Panitumumab

Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.

Intervention Type DRUG

FOLFIRI

FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

Intervention Type DRUG

Other Intervention Names

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Vectibix®

Eligibility Criteria

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Inclusion Criteria

* Man or woman at least 18 years old
* Diagnosis of metastatic colorectal cancer (mCRC)
* One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
* Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
* At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
* Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
* Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
* Adequate hematologic, renal, and hepatic functions
* Negative pregnancy test within 72 hours of enrollment
* Other protocol-specified criteria may apply

Exclusion Criteria

* History of or known presence of central nervous system (CNS) metastases
* History of another primary cancer within 5 years of randomization
* Prior irinotecan therapy
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
* Any investigational agent or therapy within 30 days before randomization
* Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
* History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
* Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV)
* Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
* Pregnant or breast-feeding
* Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
* Other protocol-specified criteria may apply

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No