NCT00006108

Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients. OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	trastuzumab
DRUG	capecitabine
DRUG	paclitaxel

Timeline

• Start date: 1999-08-01
• Primary completion: 2001-09-01
• Completion: 2002-07-01
• First posted: 2004-02-26
• Last updated: 2012-02-07

Locations

1 site across 1 country: United States