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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.
Sponsored by: Oncology Specialties, Alabama
Information provided by: Oncology Specialties, Alabama
ClinicalTrials.gov Identifier: NCT00225056
  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 II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

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

Ages Eligible for Study:   19 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: CCIBRE02
Study First Received: September 21, 2005
Last Updated: April 18, 2007
ClinicalTrials.gov Identifier: NCT00225056  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Docetaxel
Capecitabine
Skin Diseases
Breast Neoplasms
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009