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
Condition: Colon Cancer; Colorectal Cancer; Rectal Cancer; Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
Intervention: Panitumumab; Bevacizumab; mFOLFOX6
Intervention description: Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).; Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).; mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.
Intervention MeSH terms: Bevacizumab; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 285.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon Cancer; Colorectal Cancer; Rectal Cancer; Panitumumab; Vectibix; modified FOLFOX 6; mFOLFOX 6; FOLFOX; Bevacizumab; Avastin; First-Line; metastatic

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.
    

Eligibility 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.