NCT00559676CompletedPhase 4
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
Centre Hospital Regional Universitaire de Limoges2 sites in 1 country200 target enrollmentStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Oncogenetic parameters
Study Overview
Brief Summary
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary Outcomes
- Correlations between the pharmacogenetic and pharmacokinetic parameters
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
Investigators
Study Sites (2)
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