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

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00062010

Run by

Eastern Cooperative Oncology Group

People needed

37

Starts

2004-05-26

Expected to finish

2012-08-01

Last updated by the study team

2023-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Hinsdale Hematology Oncology Associates — Hinsdale, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Howard Community Hospital — Kokomo, Indiana, United States
• Center for Cancer Therapy at LaPorte Hospital and Health Services — La Porte, Indiana, United States
• Saint Anthony Memorial Health Centers — Michigan City, Indiana, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Saint Joseph Regional Medical Center — South Bend, Indiana, United States
• Mercy Capitol Hospital — Des Moines, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at John Stoddard Cancer Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at Mercy Cancer Center — Des Moines, Iowa, United States
• Mercy Cancer Center at Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Lutheran Hospital — Des Moines, Iowa, United States
• McCreery Cancer Center at Ottumwa Regional — Ottumwa, Iowa, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• Veterans Affairs Medical Center - Atlanta (Decatur) — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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