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

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel and capecitabine
Sponsored by
Oncology Specialties, Alabama
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)Female

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

Sites / Locations

  • Comprehensive Cancer Institute

Outcomes

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

Full Information

First Posted
September 21, 2005
Last Updated
April 18, 2007
Sponsor
Oncology Specialties, Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT00225056
Brief Title
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Official Title
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of accrual
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oncology Specialties, Alabama

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel and capecitabine
Primary Outcome Measure Information:
Title
Overall clinical benefit rate
Secondary Outcome Measure Information:
Title
safety and tolerability
Title
evaluate QOL
Title
determine progression free survival
Title
determine time to response and overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Waples, MD
Organizational Affiliation
Oncology Specialties, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ccihsv.com
Description
Related Info

Learn more about this trial

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

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