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.

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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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00062010

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 62 Locations for this study

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Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa Iowa, 52501, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Duluth Clinic Cancer Center - Duluth
Duluth Minnesota, 55805, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington New Jersey, 08822, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Akron City Hospital
Akron Ohio, 44309, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Mount Carmel St. Ann's Cancer Center
Westerville Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia, 25304, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00062010

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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