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
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Bevacizumab; Oxaliplatin; Panitumumab

Criteria

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.