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Phase I Study of a Novel Schedule of Capecitabine and Docetaxel in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Phase I Study of a Novel Schedule of Capecitabine and Docetaxel in Patients With Advanced Solid Tumors

This is a phase I study using an accelerated titration design to determine the maximum
tolerated dose (MTD) of capecitabine given orally on a BID schedule from days 1-14, in
combination with docetaxel given at a fixed dose of 75 mg/m2 IV on day 8. Once the MTD of
capecitabine has been determined, an additional nine patients with accessible tumors will be
treated at the MTD. Pharmacokinetics of plasma capecitabine, 5-FU,
5'-deoxy-5-fluorouridine, and docetaxel will be assayed in these nine patients, and tumor
biopsies will be taken to assess Bax:Bcl-2 ratios and Bcl-2 phosphorylation at several time
points. The primary aim of this study will be to determine the maximum tolerated dose and
dose limiting toxicities of capecitabine when given with a fixed dose of docetaxel on day 8
of a 21 day schedule. Secondary aims will include assessment of the pharmacokinetics of
capecitabine and docetaxel on this schedule, and determination of intratumoral Bax:Bcl-2,
Bcl-2 phosphorylation, and DPD expression, and correlation with clinical toxicities and
antitumor response.

Inclusion Criteria:

- Patients with a histologically or cytologically proven metastatic solid tumor.

- Patients with measurable disease or an evaluable bone lesion that will not undergo

- Patients treated within the additional cohort at MTD will have metastatic breast
cancer with a site of disease that is amenable to percutaneous FNA and must be
willing to undergo serial FNA biopsies of their primary tumor.

- Age > 18 years.

- Life expectancy of at least 6 months.

- ECOG performance status 0-2.

- Adequate hematologic, hepatic, and renal function

- Patients must have an intact upper gastrointestinal tract, be able to swallow
tablets, and not have a malabsorption syndrome.

Exclusion Criteria:

- No significant uncontrolled infectious or cardiovascular disease, or a myocardial
infarction within the prior 12 months.

- No prior organ allograft.

- No prior treatment with capecitabine or with docetaxel.

- No prior unanticipated severe reaction to fluoropyrimidine therapy or known
hypersensitivity to 5-fluorouracil.

- No concurrent antacid therapy is allowed.

- No other significant medical/surgical diseases.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose, and dose limiting toxicity of capecitabine when given daily for 14 days with docetaxel given on day 8 of a 21 day cycle

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Gary N Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2003

Completion Date:

March 2006

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • capecitabine
  • docetaxel
  • pharmacokinetic/pharmacodynamic
  • bcl-2
  • bax
  • Breast Neoplasms



Norris Cotton Cancer CenterLebanon, New Hampshire  03756