Lung Cancer Clinical Trial
Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There are 62 Locations for this study
Decatur Georgia, 30033, United States
Aurora Illinois, 60507, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60435, United States
Rockford Illinois, 61104, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Ottumwa Iowa, 52501, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Saint Joseph Michigan, 49085, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Woodbury Minnesota, 55125, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Flemington New Jersey, 08822, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10466, United States
Akron Ohio, 44309, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45801, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Charleston West Virginia, 25304, United States
Morgantown West Virginia, 26506, United States
La Crosse Wisconsin, 54601, United States
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