Vinorelbine in Treating Older Women With Stage IV Breast Cancer
- Registration Number
- NCT00022152
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.
- Detailed Description
OBJECTIVES:
* Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
* Determine the toxicity profile of this drug in these patients.
* Determine the time to progression in patients treated with this drug.
* Determine the quality of life of patients treated with this drug.
* Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.
OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then after completion of the second course.
Patients are followed every 3 months for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description vinorelbine vinorelbine tartrate Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then after completion of the second course. Patients are followed every 3 months for 5 years.
- Primary Outcome Measures
Name Time Method objective response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method time to progression Up to 5 years quality of life Up to 5 years
Trial Locations
- Locations (18)
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CentraCare Health Plaza
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States