Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Biomarker/Laboratory analysis, Treatment Active 18 and over Other CHUL-BIO-COLON RECF0356, INCA-RECF0356, NCT00559676

Objectives

Primary

1. Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects.

Secondary

1. Study the correlations between the pharmacogenetic and pharmacokinetic parameters.
2. Study the predictive value of these parameters on disease-free and overall survival.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior therapy for metastatic cancer
• Prior adjuvant chemotherapy allowed
• Concurrent bevacizumab or other monoclonal antibody therapy allowed

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

Expected Enrollment

Outcomes

Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects

Correlations between the pharmacogenetic and pharmacokinetic parameters
Predictive value of pharmacogenetic and pharmacokinetic 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.

Trial Contact Information

Trial Lead Organizations

Centre Hospital Regional Universitaire de Limoges

Nicole Tubiana-Mathieu, MD, Protocol chair		Ph: 33-5-5505-6123 Email: oncologie@chu-limoges.fr

France
	Limoges
	Centre Hospital Regional Universitaire de Limoges
		Nicole Tubiana-Mathieu, MD	Ph:  33-5-5505-6123
			Email: oncologie@chu-limoges.fr

Registry Information
Official Title		Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
Trial Start Date		2005-03-10
Registered in ClinicalTrials.gov		NCT00559676
Date Submitted to PDQ		2007-10-18
Information Last Verified		2007-11-14