NCT00277069

Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1\. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

Detailed description

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients. 2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population. 3. Determine the time to relapse after the administration of this regimen.

Conditions

• Breast
• Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
DEVICE	Capecitabine	Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
DRUG	Vinorelbine	Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days

Timeline

• Start date: 2000-05-01
• Primary completion: 2005-03-01
• Completion: 2006-03-01
• First posted: 2006-01-13
• Last updated: 2010-01-07

Locations

1 site across 1 country: United States