NCT00450515

Vinflunine and Capecitabine in Treating Patients With Previously Treated Metastatic Breast Cancer

Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the tumor response rate in patients with previously treated metastatic breast cancer treated with vinflunine and capecitabine. Secondary * Describe the adverse event profile of this regimen in these patients. * Determine the progression-free survival of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. * Describe the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every other course, and at the completion of study treatment. After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	vinflunine

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-03-22
• Last updated: 2016-12-06