Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer
- Registration Number
- NCT00499525
- Lead Sponsor
- Northwestern University
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel together with sorafenib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given together with or without sorafenib in treating patients with locally recurrent or metastatic breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare progression-free survival of patients with locally recurrent or metastatic breast cancer treated with sorafenib tosylate and paclitaxel versus placebo and paclitaxel as first-line therapy.
Secondary
* Compare the objective response rate and duration of response in patients treated with these regimens.
* Compare the time to progression in patients treated with these regimens.
* Compare the survival of patients treated with these regimens.
* Compare the safety of patients treated with these regimens.
* Compare the change from baseline in the Functional Assessment of Cancer Therapy for Breast Cancer quality of life assessment score in patients treated with these regimens.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to site of metastatic disease (visceral \[i.e., soft internal organs of the body, including lungs, heart, and the organs of the digestive, excretory, and reproductive systems\] vs nonvisceral \[i.e., osseous or soft tissue\] sites). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28.
* Arm II: Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and every 8 weeks for 24 weeks, and then every 12 weeks for the duration of study participation.
After completion of study therapy, patients are followed every 4 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II placebo Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Arm I sorafenib tosylate Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Arm I paclitaxel Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Arm II paclitaxel Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression-free survival At disease progression or death
- Secondary Outcome Measures
Name Time Method Overall response rate At the time of progression of disease Overall survival At time of death Duration of overall response At time of disease progression Time to progression At time of disease progression Treatment-emergent adverse events as assessed by NCI CTCAE v3.0 During treatment and up to 30 days post-treatment
Trial Locations
- Locations (42)
Northwest Alabama Cancer Center, PC - Muscle Shoals
🇺🇸Muscle Shoals, Alabama, United States
Highlands Oncology Group - Fayetteville
🇺🇸Fayetteville, Arkansas, United States
Pacific Cancer Medical Center, Incorporated
🇺🇸Anaheim, California, United States
Pacific Coast Hematology/Oncology Medical Group, Incorporated
🇺🇸Fountain Valley, California, United States
Desert Hematology-Oncology Medical Group, Incorporated
🇺🇸Rancho Mirage, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
🇺🇸Soquel, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Medical Oncology and Hematology, PC at Harold Leever Cancer Center
🇺🇸Waterbury, Connecticut, United States
Scroll for more (32 remaining)Northwest Alabama Cancer Center, PC - Muscle Shoals🇺🇸Muscle Shoals, Alabama, United States