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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:
Information provided by:
Oncology Specialties, Alabama
ClinicalTrials.gov Identifier:
NCT00225056
First received: September 21, 2005
Last updated: April 18, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014