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Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559676
First received: November 15, 2007
Last updated: May 13, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Oncogenetic parameters [ Designated as safety issue: No ]
  • Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlations between the pharmacogenetic and pharmacokinetic parameters [ Designated as safety issue: No ]
  • Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559676

Locations
France
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Sponsors and Collaborators
Centre Hospital Regional Universitaire de Limoges
Investigators
Study Chair: Nicole Tubiana-Mathieu, MD Centre Hospital Regional Universitaire de Limoges
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00559676     History of Changes
Other Study ID Numbers: CDR0000574159, CHUL-BIO-COLON, INCA-RECF0356
Study First Received: November 15, 2007
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Fluorouracil
Irinotecan
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014