Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer
OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell
lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the
toxicity of this treatment in these patients. III. Describe the quality of life parameters
of patients receiving this combination therapy. IV. Determine the survival rate of these
patients.
OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage
IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms
(Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by
gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II:
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and
15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Patients continue treatment every 28 days for a maximum of 6 courses in the absence of
unacceptable toxicity or disease progression. Patients with either stable disease or
complete/partial response who discontinue treatment after 4-6 courses may be eligible for
NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of
therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18
months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Edith A. Perez, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000066887
NCT00003762
February 1999
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 - 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 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |