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

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2

Details

• Lead Sponsor: Oncology Specialties, Alabama
• Treatments: Capecitabine; Docetaxel

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