S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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.
PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||October 1998|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
AUC=5.5 day 1 every 21 days X 3
Other Name: carboDrug: gemcitabine
IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3
Other Name: gemzarDrug: paclitaxel
IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
Other Name: taxol
IV cisplatin 100 mg/m^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
IV cisplatin 100 mg/m^2 day 1 every 21 days X 3
Other Name: platinolDrug: docetaxel
IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
Other Name: taxotereDrug: vinorelbine
IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3
Other Name: navelbine
OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.