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Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to Capecitabine Chemotherapy in Colon Cancer Treatment
This study is currently recruiting participants.
Verified by Alberta Cancer Board, April 2007
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00126867
  Purpose

Cancers of the colon and rectum are the third most common cancers in Canadian males and females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby lymph glands. If the cancer has spread to the lymph glands there is a high chance that the cancer will come back. To reduce the risk of the cancer recurring, patients are treated with an anticancer drug capecitabine. This study will determine if a simple blood test can predict which patients are at risk for developing side effects from this chemotherapy. In addition, participants of this study will be followed to determine if this same blood test will predict which patients will have their cancer relapse.


Condition
Colon Cancer

MedlinePlus related topics: Cancer
Drug Information available for: Capecitabine
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to Capecitabine Based Adjuvant Chemotherapy in Colon Cancer Treatment

Further study details as provided by Alberta Cancer Board:

Estimated Enrollment: 104
Study Start Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk Stage II or III colon cancer
  • Eastern Cooperative Oncology Group performance status (ECOG P.S.) O or l
  • No prior chemotherapy
  • Complete tumor resection
  • Candidate for and planned to receive standard capecitabine
  • Adequate bone marrow reserve

Exclusion Criteria:

  • Known DED deficiencies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126867

Contacts
Contact: Karen Mulder, MD 780-432-8826 karenmul@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Clinical Research Unit     780-989-8152     clinical_trials_cci@cancerboard.ab.ca    
Principal Investigator: Karen Mulder, MD            
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Karen Mulder, MD Alberta Cancer Board
Principal Investigator: Michael Sawyer, MD Alberta Cancer Board
  More Information

Study ID Numbers: GI-05-0049
Study First Received: August 3, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00126867  
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
thymidylate synthase polymers
rapecitabine
adjuvant
colon cancer
toxicity
Stage II colon cancer
Stage III colon cancer
adenocarcinoma of the colon

Study placed in the following topic categories:
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Adenocarcinoma
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009