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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel and capecitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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John M Waples, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Specialties, PC

Locations

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Comprehensive Cancer Institute

Huntsville, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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CCIBRE02

Identifier Type: -

Identifier Source: org_study_id