Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, 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, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or metastatic colorectal cancer.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer|
- Improvement of hematologic and gastrointestinal tolerance to therapy [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
- Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.
- Increase the effectiveness of this regimen by intensifying the treatment.
- Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
- Assess the time to progression.
OUTLINE: This is a multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Pharmacokinetic and pharmacogenetic studies are also conducted.