RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed. PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Response by RECIST Criteria (v 1.0)
Number of eligible, treated participants in each response category by RECIST criteria
Time frame: Assessed every 6 weeks
Survival
Time from registration to death.
Time frame: Assessed every 3 months for 1 year then every 6 months
Progression-free Survival
Time from registration to documented disease progression (RECIST criteria) or death.
Time frame: Assessed every 6 weeks
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