Panitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT00655499
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    6 mg/kg
  • Irinotecan hydrochloride — DRUG
    180 mg/kg
  • Chromogenic in situ hybridization — GENETIC
  • Fluorescence in situ hybridization — GENETIC
  • Gene expression analysis — GENETIC
  • Laboratory biomarker analysis — OTHER

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Aug 2016
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
65 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Panitumumab + CPT11 (irinotecan hydrochloride)
    1 cycle every 14 days (J1= J15)

Primary Outcome Measure

Objective Response Rate (ORR) During the Combination Therapy Phase [ Time Frame: Up to 20 months ]

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