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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

May 23, 2007
October 5, 2012
May 2007
May 2014   (final data collection date for primary outcome measure)
Incidence of DPYD variants in patients [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00478686 on ClinicalTrials.gov Archive Site
Not Provided
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Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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).
Probability Sample

Patients with breast cancer who experienced toxicity/side effects related to capecitabine chemotherapy.
Breast Cancer
Procedure: Phlebotomy
5 to 7.5 milliliter (mL) Blood Sample
  • Severe Toxicity
    Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy
    Intervention: Procedure: Phlebotomy
  • Dose-Limiting Toxicity
    Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy
    Intervention: Procedure: Phlebotomy
  • Low/No Toxicity
    Patients who have experienced low/no toxicity (none or only side effects at grade 1 & 2) with capecitabine chemotherapy.
    Intervention: Procedure: Phlebotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00478686
2006-1003
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Myrexis Inc.
Principal Investigator: Phuong K. Morrow, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP