Lung Cancer Clinical Trial
Official title:
Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
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 combination chemotherapy in treating
patients who have extensive-stage small cell lung cancer.
OBJECTIVES:
- Determine the survival of patients with extensive stage small cell lung cancer treated
with gemcitabine and irinotecan.
- Determine the response rates (confirmed and unconfirmed, complete and partial) of
patients treated with this regimen.
- Determine the overall toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on
days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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