A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer
Prior therapy including either cisplatin or carboplatin with progression either on therapy
or within 3 months of completing therapy Bidimensionally measurable disease on CT scan or
x-ray, not limited to the CNS No active CNS disease CNS metastasis allowed if measurable
disease outside of CNS and completed a course of CNS radiotherapy if clinically indicated
and recovered

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Zubrod 0-2 Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST
no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2
times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50
mL/min Cardiovascular: No evidence of heart block greater than first degree, bundle branch
block, or ventricular or supraventricular arrhythmia on EKG No clinical evidence of
congestive heart failure, angina, or documented myocardial infarction within past 6 months
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No known hypersensitivity to Cremaphor EL No other significant concurrent
medical or psychiatric condition that might place patient at increased risk from study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
At least 4 weeks since prior radiotherapy to only site of measurable disease or to greater
than 20% of bone marrow Surgery: Not specified Other: No other concurrent experimental
drugs or cancer therapy