Lung Cancer Clinical Trial
Official title:
Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for 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 combination chemotherapy in treating
patients who have recurrent or refractory small cell lung cancer.
OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with
recurrent or refractory small cell lung cancer when treated with gemcitabine plus
irinotecan. II. Determine the overall and failure free survival of these patients when
treated with this regimen. III. Determine the duration of response of these patients after
this treatment. IV. Evaluate the toxicity associated with the administration of this
treatment in this patient population.
OUTLINE: Patients are stratified according to prior response duration (progression 90 days
or more after initial therapy vs progression less than 90 days after initial therapy or no
response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan
IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months for 1
year, then every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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