Combination Chemotherapy in Treating Patients With Extensive-Stage 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. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Drug: topotecan hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung|
|Study Start Date:||September 2001|
|Study Completion Date:||November 2002|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
Active Comparator: oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
|Drug: cisplatin Drug: topotecan hydrochloride|
Experimental: Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
|Drug: cisplatin Drug: etoposide|
- Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
- Compare the response rates, response duration, and time to progression in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the patient-perceived disease status and well being in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.
Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Nathan Levitan, MD||Case Comprehensive Cancer Center|