Spots Global Cancer Trial Database for Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title: A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer
Study ID: NCT00003299
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic, Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Medcenter One Health System, Bismarck, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Altru Health Systems, Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Harvey B. Niell, MD
Affiliation: Veterans Affairs Medical Center - Memphis
Role: STUDY_CHAIR
Name: Randolph S. Marks, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
Name: Alan B. Sandler, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
Name: Karen Kelly, MD
Affiliation: University of Colorado, Denver
Role: STUDY_CHAIR
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