Phase II Trial of Gemcitabine and Irinotecan in Patients with Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

Pts. must have histologically or cytologically proven, extensive SCLC; pts. must have measurable or non-measurable dz by CT, MRI X-ray, nuclear or physical exam; controlled brain mets are allowed (w/o symptoms or after completion of treatment w/RT or surgery); AGC >= 1,500, WBC >= 3,000, PLTS >= 100,000; bili <= 1.25 X IULN; SGOT or SGPT <= 2.5 X IULN; PS 0-2; no prior malignancy except basal or squamous skin, in situ cervical, treated St I or II ca from which pt. is in complete remission or any other ca pt. has been dz-free of for 5 yrs; pts. must not have any other lung cancer; pts. must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; pts. must not have had prior systemic chemo, biologic or RT for SCLC.