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A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer

Combination chemotherapy has advantages over monochemotherapy due to the higher response
rates that can often be obtained; by using agents with non-overlapping toxicity profiles,
these responses can be achieved with less toxicity than maximally tolerated doses of single
agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy
is that both agents appear to have a toxicity profile appropriate for palliative therapy of
advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in
the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes
of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a
one-week rest to coincide with the 14-day schedule of capecitabine.

The primary objective is to evaluate the overall response rate (complete and partial
responses) according to the RECIST criteria of the combination of capecitabine and docetaxel
with the selected schedule in patients with advanced and/or metastatic breast cancer. The
secondary objectives are to evaluate tolerability, time to tumor progression, and time to
treatment failure of the combination of capecitabine and docetaxel.

Inclusion Criteria:

- Female patients with histopathologically proven metastatic breast cancer.

- Patients 18-75 years old

- Performance status: Karnofsky > 70%

- Patients must have measurable disease. Patients with only blastic bone lesions are

- Adequate bone marrow, liver, renal and cardiac functions defined as:

- Ability to understand the study and give informed consent.

- Patients may not have received more than one prior chemotherapy for metastatic breast
cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the
patient ineligible.

Exclusion Criteria:

- Patients with brain metastasis, adequately treated and stable and not requiring
continued steroid medication will be eligible if no progression for > 3 months.

- Patients who have received any anti-cancer investigational agent in the month prior
to inclusion.

- Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).

- Patients with lack of physical integrity of the upper gastrointestinal tract,
inability to swallow tablets or those who have malabsorption syndrome.

- Patients with renal impairment (creatinine clearance below 30 ml/min calculated
according to Cockcroft and Gault, see Appendix D), since capecitabine is
contraindicated in patients with severe renal impairment.

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 find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Charles L Vogel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Research Network, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • Taxotere (docetaxel)
  • Xeloda (capecitabine)
  • Breast Neoplasms



Cancer Research Network, Inc. Plantation, Florida  33324