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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00960544
First received: August 17, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling) [ Time Frame: PK tesing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine
Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
Drug: Capecitabine
Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
Other Name: Xeloda

Detailed Description:

Capecitabine, PK Testing, and DNA Analysis:

Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (which are made from DNA--the gene material of cells). Some patients have changes in these proteins that increase or decrease the rate that capecitabine is cleared from the body.

Researchers will use pharmacokinetic (PK) testing and DNA analysis to learn how capecitabine is cleared from your body. PK testing measures the amount of drug in the body at different time points. Information learned in this study may help researchers decide the best doses of capecitabine for future patients with breast cancer.

Screening Visit:

Before you can start treatment on this study, you will have about 2 teaspoons of blood drawn for routine tests and to make sure that you are able to receive chemotherapy. This screening blood test will help the study doctor decide if you are eligible to take part in this study.

Capecitabine Treatment:

If you are found to be eligible to take part in this study, you will be given capecitabine by mouth on the day you choose to start this therapy. Your treating doctor will prescribe capecitabine at a dose that is appropriate to treat the cancer. You can choose the start date, excluding weekends, but will need to begin therapy in the morning of the day you choose. You will have treatment with capecitabine even if you do not participate on this study.

PK Testing and DNA Analysis:

You will have blood drawn (about 2 teaspoons each time) for PK testing and DNA analysis of capecitabine at certain times throughout this study.

  • For PK testing, blood will be drawn before your first dose of capecitabine, at 30, 60, and 90 minutes after the first dose, and then at 2, 6, 8, and 10 hours after the first dose.
  • For DNA analysis, blood will only be drawn before you receive the first dose of capecitabine.

If your dose changes, these PK blood tests may need to be repeated.

Length of Study:

You will remain on this study for up to 6 months, unless the disease gets worse, you experience any intolerable side effects, or you decide to stop treatment with capecitabine.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

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

Inclusion Criteria:

  1. Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
  2. Patients must give informed consent for protocol participation.
  3. Age >/= 18 years
  4. Patients must have and ECOG performance status of </=2.
  5. Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
  6. Patients must agree to blood draws for PK/PD sampling.
  7. Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
  8. Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
  9. Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
  10. 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.
  11. 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.

Exclusion Criteria:

  1. Untreated or uncontrolled brain metastasis
  2. History of prior therapy with capecitabine
  3. Patient inability to take or absorb oral medications
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960544

Contacts
Contact: Phuong Khanh Morrow, MD 713-792-2817

Locations
United States, Texas
UT MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Phuong Khanh Morrow, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Myriad Genetic Laboratories, Inc.
Investigators
Study Chair: Phuong Khanh Morrow, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00960544     History of Changes
Other Study ID Numbers: 2007-0003
Study First Received: August 17, 2009
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Capecitabine
Xeloda
Gene expression
Pharmacokinetic testing
PK sampling
DNA analysis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014