Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism

NCT00960544 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2007-0003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.

Conditions

Breast Cancer

Keywords

Capecitabine; Xeloda; Gene expression; Pharmacokinetic testing; PK sampling; DNA analysis

Outcome Measures

Primary Outcomes (1)

• Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)

  Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)

  PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.

Study Arms (1)

Capecitabine

EXPERIMENTAL

Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.

Drug: Capecitabine

Interventions

Capecitabine DRUG

Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
• Patients must give informed consent for protocol participation.
• Age \>/= 18 years
• Patients must have and ECOG performance status of \</=2.
• Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
• Patients must agree to blood draws for PK/PD sampling.
• Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
• Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
• Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
• Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. Both men and women should practice an effective method of birth control while receiving capecitabine.
• Patients must have recovered to grade \<1 from all acute toxicity of previous chemotherapy, radiation or hormonal therapy and have adequate hematologic and hepatic function: Granulocyte count \>/= 1,500/mcL; Platelet count \>/= 100,000/mcL; Bilirubin \</= 1.5 x ULN; AST and/or ALT \</= 2 x ULN; Alkaline phosphatase (liver component, if fractionated) \</= 2 x ULN; Serum creatinine within normal limits.

You may not qualify if:

• Untreated or uncontrolled brain metastasis
• History of prior therapy with capecitabine
• Patient inability to take or absorb oral medications

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Myriad Genetic Laboratories, Inc.: collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Phuong Khanh Morrow, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: June 14, 2019

Record last verified: 2019-06