Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
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.
|Lung Cancer||Biological: interferon alpha Drug: 13-cis-retinoic acid Drug: paclitaxel||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer|
- Response by RECIST Criteria (v 1.0) [ Time Frame: Assessed every 6 weeks ]Number of eligible, treated participants in each response category by RECIST criteria
- Survival [ Time Frame: Assessed every 3 months for 1 year then every 6 months ]Time from registration to death.
- Progression-free Survival [ Time Frame: Assessed every 6 weeks ]Time from registration to documented disease progression (RECIST criteria) or death.
|Study Start Date:||February 2004|
|Study Completion Date:||August 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: IFN-alpha, 13-CRA, paclitaxel
Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle
Biological: interferon alpha
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.
Other Names:Drug: 13-cis-retinoic acid
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.
Other Names:Drug: paclitaxel
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062010
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|Study Chair:||Joseph Aisner, MD||Rutgers Cancer Institute of New Jersey|