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

Completed · Phase 2

Conditions studied: Colon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00819780

Run by

Amgen

People needed

285

Starts

2009-04-24

Expected to finish

2016-07-07

Last updated by the study team

2022-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Berkeley, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Burbank, California, United States
• Research Site — Fountain Valley, California, United States
• Research Site — La Verne, California, United States
• Research Site — Orange, California, United States
• Research Site — Riverside, California, United States
• Research Site — Roseville, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Lake Worth, Florida, United States
• Research Site — Alpharetta, Georgia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Post Falls, Idaho, United States
• Research Site — Gurnee, Illinois, United States
• Research Site — Peoria, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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