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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:April 24, 2009
End Date:July 7, 2016

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A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

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.


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.
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