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A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00214864
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: docetaxel, capecitabine Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
Study Start Date : December 2002
Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: docetaxel, capecitabine
    cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8

Outcome Measures

Primary Outcome Measures :
  1. To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ineligible.
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214864


Locations
United States, Florida
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
Sponsors and Collaborators
Cancer Research Network
Hoffmann-La Roche
Investigators
Principal Investigator: Charles L Vogel, MD Cancer Research Network, Inc
Study Chair: Elizabeth Tan-Chiu, MD Cancer Research Network, Inc.
More Information

Responsible Party: Cancer Research Network
ClinicalTrials.gov Identifier: NCT00214864     History of Changes
Other Study ID Numbers: CRN-003
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Cancer Research Network:
Metastatic Breast Cancer
Taxotere (docetaxel)
Xeloda (capecitabine)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites