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


Phase 2
19 Years
85 Years
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall clinical benefit rate

Principal Investigator

John M Waples, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Specialties, PC

Authority:

United States: Food and Drug Administration

Study ID:

CCIBRE02

NCT ID:

NCT00225056

Start Date:

October 2003

Completion Date:

November 2006

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms
  • Carcinoma

Name

Location

Comprehensive Cancer InstituteHuntsville, Alabama  35801