Lung Cancer Clinical Trial
Official title:
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed 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: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating
patients who have recurrent or refractory small cell lung cancer.
OBJECTIVES:
- Determine the toxicity of combination topotecan and paclitaxel in previously treated
patients with small cell lung cancer.
- Determine the response rate and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time
since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)).
Stratum A closed to accrual effective 06/20/2000.
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on
day 3. Courses repeat every 4 weeks.
Patients who achieve partial response or stable disease continue treatment in the absence of
complete response or disease progression. Patients who develop disease progression in the
CNS only should receive whole brain radiotherapy and then continue treatment. Patients who
achieve complete remission receive a maximum of 6 courses of treatment. Patients may then
undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at
the attending physician.
Patients are followed every 3 months for 2 years and then at 3 years after study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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