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