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

Oncology Specialties, Alabama

Status and phase

Terminated

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: docetaxel and capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00225056

CCIBRE02

Details and patient eligibility

About

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.

Sex

Female

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

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