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

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine; Drug: vinflunine

• Registration Number: NCT00450515
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-22
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vinflunine + capecitabine	vinflunine	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.
vinflunine + capecitabine	capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Confirmed tumor response	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 10 years
Quality of life	Up to 10 years
Duration of response	Up to 10 years
Time to treatment failure	Up to 10 years
Adverse event profile	Up to 10 years
Progression-free survival	Up to 10 years