An Open-label Phase II Trial of Panitumumab Plus Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild-type) in Third-line Chemotherapy (FOLFOX/XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI/CAPIRI ± Bevacizumab) (PIMABI)

NCT00655499 Phase 2 COMPLETED Results posted

RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells. PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.

Details

Lead sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Phase	Phase 2
Status	COMPLETED
Enrolment	65
Start date	2008-06
Completion	2012-06

Conditions

• Colorectal Cancer

Interventions

• Panitumumab
• Irinotecan hydrochloride
• Chromogenic in situ hybridization
• Fluorescence in situ hybridization
• Gene expression analysis
• Laboratory biomarker analysis

Primary outcomes

• Objective Response Rate (ORR) During the Combination Therapy Phase — Up to 20 months
  Per the modified Response Evaluation Criteria in Solid Tumors (m-RECIST) for target lesions and radiogically assessed (CT Scans; optionally MRI): Complete Response (CR; Disappearance of all target lesions) or Partial Response (PR; At least a 30% decrease in the sum of the LD of target lesions) during the combination therapy phase.Overall Response (OR) = CR + PR.

Countries

France