Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

OBJECTIVES:

• Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
• Determine the toxic effects of this regimen in these patients.
• Determine the duration of survival in patients treated with this regimen.
• Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Inclusion criteria

• Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
• Age 18 and over
• ECOG Performance status 0-3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 2 times upper limit of normal (ULN)
• Creatinine no greater than 1.5 mg/dL
• Triglycerides no greater than 1.5 times ULN
• Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have resolved to less than or equal to grade 1
• Women of childbearing potential and sexually active males are strongly encouraged to use an accepted and effective method of contraception.

Exclusion criteria

• History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
• Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
• Severe depression requiring medication
• Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
• Use of GM-CSF or G-CSF within 4 weeks prior to registration
• Prior paclitaxel or interferon therapy
• Radiation therapy within 60 days prior to registration
• Chemotherapy within 60 days prior to registration