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Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

This study has been terminated.
(Terminated due to lack of accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225056
First Posted: September 23, 2005
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oncology Specialties, Alabama
  Purpose
In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.

Condition Intervention Phase
Metastatic Breast Cancer Drug: docetaxel and capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Oncology Specialties, Alabama:

Primary Outcome Measures:
  • Overall clinical benefit rate

Secondary Outcome Measures:
  • safety and tolerability
  • evaluate QOL
  • determine progression free survival
  • determine time to response and overall survival

Estimated Enrollment: 43
Study Start Date: October 2003
Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • must have metastatic breast cancer
  • must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
  • must have measurable or evaluable disease
  • ECOG of 0-1
  • patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
  • must have adequate organ function
  • must be at least 19 years of age
  • peripheral neuropathy less than or equal to grade 1
  • must have voluntarily signed informed consent
  • patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled

Exclusion Criteria:

  • patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
  • patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
  • known uncontrolled existing coagulopathy
  • patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
  • use of other investigational agents in the last 28 days
  • pregnant or lactating women
  • patients who are known HIV positive
  • patients with life expectancy of less than 3 months
  • sexually active patients unwilling to practice reliable contraception during the study
  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): NCT00225056


Locations
United States, Alabama
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
Oncology Specialties, Alabama
Investigators
Principal Investigator: John M Waples, MD Oncology Specialties, PC
  More Information

ClinicalTrials.gov Identifier: NCT00225056     History of Changes
Other Study ID Numbers: CCIBRE02
First Submitted: September 21, 2005
First Posted: September 23, 2005
Last Update Posted: April 20, 2007
Last Verified: April 2007

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