Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy
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.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7-18
months.
Interventional
Primary Purpose: Treatment
Edith A. Perez, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068790
NCT00022152
November 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |