PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Amgen

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Drug: Bevacizumab; Drug: mFOLFOX6; Drug: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819780

20070509

Details and patient eligibility

About

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Enrollment: 285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
• Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
• Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Men or women 18 years of age or older
• Adequate hematologic, renal, hepatic, metabolic, and coagulation function

Exclusion criteria

• History of prior or concurrent central nervous system (CNS) metastases
• Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
• Clinically significant cardiac disease
• Clinically significant peripheral sensory neuropathy
• Active inflammatory bowel disease
• Recent gastroduodenal ulcer to be active or uncontrolled
• History of interstitial lung disease
• Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
• Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
• Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 2 patient groups

Panitumumab Plus mFOLFOX6

Experimental group

Description:

Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2) and 5-fluorouracil (5-FU) (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Treatment:

Drug: Panitumumab

Drug: mFOLFOX6

Bevacizumab Plus mFOLFOX6

Active Comparator group

Description:

Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2), followed by 5-FU (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Treatment:

Drug: mFOLFOX6

Drug: Bevacizumab