NCT00662129

Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (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 gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab. Secondary * To determine the overall survival of patients treated with this regimen. * To determine the progression-free survival of patients treated with this regimen. * To determine the confirmed response rate in patients treated with this regimen. * To determine the duration of response in patients treated with this regimen. * To determine the time to treatment failure in patients treated with this regimen. * To determine the quality of life of patients treated with this regimen. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after every other course, and then after completion of treatment. After completion of study treatment, patients are followed periodically for 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	gemcitabine hydrochloride
DRUG	paclitaxel albumin-stabilized nanoparticle formulation

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-08-01
• Completion: 2013-08-01
• First posted: 2008-04-21
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

92 sites across 1 country: United States