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Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan

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

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

- For DNA analysis, blood will only be drawn before you receive the first dose of

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.

Inclusion Criteria:

1. Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the

2. Patients must give informed consent for protocol participation.

3. Age >/= 18 years

4. Patients must have and ECOG performance status of
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

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
Exclusion Criteria:

1. Untreated or uncontrolled brain metastasis

2. History of prior therapy with capecitabine

3. Patient inability to take or absorb oral medications

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Safety Issue:


Principal Investigator

Phuong Khanh Morrow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Capecitabine
  • Xeloda
  • Gene expression
  • Pharmacokinetic testing
  • PK sampling
  • DNA analysis
  • Breast Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030