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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Myrexis Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00478686
First received: May 23, 2007
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

Primary Objective:

1. To evaluate the incidence of DPYD variants in patients who are enrolled in the UT M.D. Anderson phase III trial (ID 01-580), which evaluates the effect of differing taxanes/taxane combinations on the outcome of patients with operable breast cancer.

Secondary Objective:

1. To determine the extent to which DPYD variants correlate to toxicity related to capecitabine.

Exploratory Objective:

1. To evaluate polymorphisms (SNPs) of thymidylate synthase (TS), MTHFR, OPRT and thymidine phosphorylase (TP) and correlate these results with capecitabine/5-FU toxicity.


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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of DPYD variants in patients [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

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).


Estimated Enrollment: 210
Study Start Date: May 2007
Estimated Primary Completion Date: May 2014 (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

Genders Eligible for Study:   Both
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 ID01-580 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478686

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Myrexis Inc.
Investigators
Principal Investigator: Phuong K. Morrow, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00478686     History of Changes
Other Study ID Numbers: 2006-1003
Study First Received: May 23, 2007
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Dihydrouracil Dehydrogenase (NADP)
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013