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

April 18, 2007 updated by: Oncology Specialties, Alabama
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Comprehensive Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall clinical benefit rate

Secondary Outcome Measures

Outcome Measure
safety and tolerability
evaluate QOL
determine progression free survival
determine time to response and overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncology Specialties, Alabama

Investigators

  • Principal Investigator: John M Waples, MD, Oncology Specialties, PC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

April 20, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCIBRE02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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