An Open-Label, Multicenter, Randomized, Phase II Study of Topotecan/Paclitaxel vs Etoposide/Cisplatin as First-Line Therapy for Patients With Extensive Disease Small Cell Lung Cancer
OBJECTIVES: I. Compare the response rates in patients with extensive stage small cell lung
cancer treated with topotecan and paclitaxel versus etoposide and cisplatin. II. Compare
time to response, response duration, time to progression, and survival in these patients
treated with these regimens. III. Determine the toxicity profiles of these regimens in these
patients. IV. Compare the effects of these regimens on symptoms of disease in these
patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to gender, ECOG performance status (0-1 vs 2), and elevated LDH (absent vs
present). Patients are randomized to one of two treatment arms. Arm I: Patients receive
paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Patients
also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood
counts recover. Arm II: Patients receive cisplatin IV over 3 hours on day 1 and etoposide IV
over 30 minutes on days 1-3. Treatment continues every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 3
months.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
Nathan Levitan, MD
Study Chair
Case Comprehensive Cancer Center
United States: Federal Government
CDR0000068248
NCT00006374
October 1999
Name | Location |
---|---|
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |