Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Improvement of hematologic and gastrointestinal tolerance to therapy
Erick Gamelin, MD
ICO Paul Papin
United States: Federal Government