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

NCT00225056 | Terminated Phase 2

• 1 other identifier: CCIBRE02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall clinical benefit rate

Secondary Outcomes (4)

• safety and tolerability

• evaluate QOL

• determine progression free survival

• determine time to response and overall survival

Interventions

docetaxel and capecitabine DRUG

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Specialties, Alabama: lead

Study Sites (1)

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• John M Waples, MD

  Oncology Specialties, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: October 1, 2003
• Study Completion: November 1, 2006
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

US (1)