Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559676
• Other study ID #: CDR0000574159
• Secondary ID: CHUL-BIO-COLONIN
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2007
• Last updated: May 13, 2011
• Start date: March 2005

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• capecitabine

• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

• oxaliplatin

Other:
• laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
France	Centre Hospital Regional Universitaire de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospital Regional Universitaire de Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncogenetic parameters			No
Primary	Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects			Yes
Secondary	Correlations between the pharmacogenetic and pharmacokinetic parameters			No
Secondary	Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival			No