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 |
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.
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.
We found this trial at
63
sites
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