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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225056
• Other study ID #: CCIBRE02
• Status: Terminated
• Phase: Phase 2
• First received: September 21, 2005
• Last updated: April 18, 2007
• Start date: October 2003
• Est. completion date: November 2006

Study information

• Verified date: April 2007
• Source: Oncology Specialties, Alabama
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: November 2006
• Gender: Female
• Age group: 19 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• docetaxel and capecitabine

Locations

Country	Name	City	State
United States	Comprehensive Cancer Institute	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Oncology Specialties, Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clinical benefit rate
Secondary	safety and tolerability
Secondary	evaluate QOL
Secondary	determine progression free survival
Secondary	determine time to response and overall survival