Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00559741|
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Other: pharmacological study||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2011|
- Improvement of hematologic and gastrointestinal tolerance to therapy
- Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
- Time to progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559741
|Centre Paul Papin|
|Angers, France, 49036|
|Study Chair:||Erick Gamelin, MD||Institut Cancerologie de l'Ouest|