Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy
OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or
IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to
progression in patients treated with this drug. III. Determine the toxicity of this drug in
these patients. IV. Determine whether there is a perceived preference for this oral
administration in these patients. V. Determine the quality of life of these patients when
treated with this drug. VI. Assess individual variation in responses, pharmacokinetic
parameters, and/or biological correlates in patients treated with this drug.
OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every
28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed
every 3 months for 5 years.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study within 1.3 years.
Primary Purpose: Treatment
Aminah Jatoi, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|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|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|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|