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Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478686
First Posted: May 25, 2007
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Myrexis Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.

Condition Intervention
Breast Cancer Procedure: Phlebotomy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of DPYD variants in patients [ Time Frame: 2 Years ]

Biospecimen Retention:   Samples With DNA
5 to 7.5 milliliter (mL) sample of blood. Alternatively, DNA will be extracted from 10um slices of formalin-fixed paraffin-embedded tissue from previously collected tumor tissue (from the time of the breast cancer diagnosis).

Enrollment: 102
Actual Study Start Date: May 23, 2007
Study Completion Date: May 2, 2017
Primary Completion Date: May 2, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Severe Toxicity
Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy
Procedure: Phlebotomy
5 to 7.5 milliliter (mL) Blood Sample
Dose-Limiting Toxicity
Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy
Procedure: Phlebotomy
5 to 7.5 milliliter (mL) Blood Sample
Low/No Toxicity
Patients who have experienced low/no toxicity (none or only side effects at grade 1 & 2) with capecitabine chemotherapy.
Procedure: Phlebotomy
5 to 7.5 milliliter (mL) Blood Sample

Detailed Description:

If you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research.

If you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). The tumor samples will be used for genetic research.

After the blood draw or tissue collection, your participation in this study will be over.

The blood samples for the genetic research will be stored at Myriad Laboratories. Before your blood and/or tissue is sent to Myriad Laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by Myriad Laboratories for additional research.

This is an investigational study. Up to 210 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with breast cancer who experienced toxicity/side effects related to capecitabine chemotherapy.
Criteria

Inclusion Criteria:

  1. Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study.
  2. Patients must sign an informed consent for this protocol.

Exclusion Criteria:

1) There are no exclusion criteria.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478686


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Myrexis Inc.
Investigators
Principal Investigator: Vicente Valero, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00478686     History of Changes
Other Study ID Numbers: 2006-1003
First Submitted: May 23, 2007
First Posted: May 25, 2007
Last Update Posted: May 8, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Dihydropyrimidine Dehydrogenase
DPYD
DPYD Variants
Toxicity
Capecitabine
Xeloda

Additional relevant MeSH terms:
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents


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