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 survival At time of death Duration of overall response At time of disease progression Time to progression At time of disease progression Overall response rate At the time of progression of disease Treatment-emergent adverse events as assessed by NCI CTCAE v3.0 During treatment and up to 30 days post-treatment
Trial Locations
- Locations (42)
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Northwest Alabama Cancer Center, PC - Muscle Shoals
🇺🇸Muscle Shoals, Alabama, United States
Pacific Cancer Medical Center, Incorporated
🇺🇸Anaheim, California, United States
Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
🇺🇸Soquel, 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
Pasco Hernando Oncology Associates, PA - Brooksville
🇺🇸Brooksville, Florida, United States
Pasco Hernando Oncology Associates, PA - New Port Richey
🇺🇸New Port Richey, Florida, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
🇺🇸Athens, Georgia, United States
Cancer Institute at Alexian Brothers
🇺🇸Elk Grove Village, Illinois, United States
Medical and Surgical Specialists, LLC
🇺🇸Galesburg, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Kellogg Cancer Care Center
🇺🇸Oak Park, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
🇺🇸Skokie, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Kentuckiana Cancer Institute, PLLC
🇺🇸Louisville, Kentucky, United States
Family Medicine of Vincennes Clinical Trial Center
🇺🇸Vincennes, Indiana, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸Columbia, Missouri, United States
Nebraska Hematology-Oncology, PC
🇺🇸Lincoln, Nebraska, United States
Piedmont Hematology-Oncology Associates
🇺🇸Winston-Salem, North Carolina, United States
Tri-County Hematology/Oncology Associates, Incorporated
🇺🇸Canton, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
West Clinic - East Memphis
🇺🇸Memphis, Tennessee, United States
Hematology and Oncology Associates of Rhode Island
🇺🇸Cranston, Rhode Island, United States
Patients' Comprehensive Cancer Center - Carrollton
🇺🇸Carrollton, Texas, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Hematology-Oncology Associates of Illinois
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Hematology Oncology Consultants, Incorporated
🇺🇸Columbus, Ohio, United States
Highlands Oncology Group - Fayetteville
🇺🇸Fayetteville, Arkansas, 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
George Washington University Cancer Institute
🇺🇸Washington, District of Columbia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Essex Oncology of North Jersey
🇺🇸Belleville, New Jersey, United States
Sussex County Medical Associates - Sparta
🇺🇸Sparta, New Jersey, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
🇺🇸Kirkland, Washington, United States
Oncology Consultants - Memorial City
🇺🇸Houston, Texas, United States