A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer
OBJECTIVES: I. Determine whether the addition of paclitaxel to standard chemotherapy
treatment comprising etoposide and cisplatin improves the survival of patients with
extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free
survival of these patients treated with these regimens. III. Describe and compare the toxic
effects associated with these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to performance status
and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive
cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3. Arm II: Patients receive
paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I. Patients then
receive filgrastim (G-CSF) subcutaneously on days 4-18. Treatment repeats in both arms every
21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at least every 2 months for 2 years, every 4 months for 1 year, and
then at least every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 670 patients (335 per arm) will be accrued for this study
within 16 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Harvey B. Niell, MD
Study Chair
Veterans Affairs Medical Center - Memphis
United States: Food and Drug Administration
CDR0000066238
NCT00003299
April 1998
January 2006
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 - 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 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
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 |
Medcenter One Health System | Bismarck, North Dakota 58501 |