Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
OBJECTIVES:
Primary
- Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors
of therapeutic response and toxic effects.
Secondary
- Study the correlations between the pharmacogenetic and pharmacokinetic parameters.
- Study the predictive value of these parameters on disease-free and overall survival.
OUTLINE: This is a multicenter study.
Patients receive 1 of 4 chemotherapy regimens:
- Regimen 1: Fluorouracil and leucovorin calcium
- Regimen 2: Capecitabine and leucovorin calcium
- Regimen 3: Irinotecan hydrochloride
- Regimen 4: Oxaliplatin Tumor and blood samples are collected before the start of
chemotherapy and are examined by pharmacogenetic analysis. Clinical and biological
parameters are also studied. Blood samples are also collected during the first course
of chemotherapy for pharmacokinetic studies.
After completion of study therapy, patients are followed periodically for 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic colorectal cancer
- Unresectable metastatic disease must be confirmed histologically if > 2 years
since primary diagnosis
- Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods
- Scheduled to receive first-line chemotherapy for metastatic disease
- Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride,
or oxaliplatin
- No inadequate or unusable tissue as the only tissue available
- No known brain metastases or meningeal disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No contraindication to chemotherapy
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other severe pathology that is likely to worsen during therapy
- No dementia or severely impaired mental condition
- No geographical or psychological reasons that would preclude treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy for metastatic cancer
- Prior adjuvant chemotherapy allowed
- Concurrent bevacizumab or other monoclonal antibody therapy allowed
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Oncogenetic parameters
Safety Issue:
No
Principal Investigator
Nicole Tubiana-Mathieu, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospital Regional Universitaire de Limoges
Authority:
United States: Federal Government
Study ID:
CDR0000574159
NCT ID:
NCT00559676
Start Date:
March 2005
Completion Date:
Related Keywords:
- Colorectal Cancer
- recurrent colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|
