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

Condition(s) targeted: Lung Cancer

Intervention: interferon alpha (Biological); 13-cis-retinoic acid (Drug); paclitaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Joseph Aisner, MD, Study Chair, Affiliation: Rutgers Cancer Institute of New Jersey

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.

Official title: Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response by RECIST Criteria (v 1.0)

Secondary outcome:

Survival

Progression-free Survival

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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 61104-2315, 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

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316, 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

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa 52501, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States

Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States

Hutchinson Area Health Care, Hutchinson, Minnesota 55350, United States

Meeker County Memorial Hospital, Lichfield, Minnesota 55355, United States

HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota 55109, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota 55415, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota 55407, United States

St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota 55379, United States

HealthEast Cancer Care at St. Joseph's Hospital, St Paul, Minnesota 55102, United States

Regions Hospital Cancer Care Center, St. Paul, Minnesota 55101, 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

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada 89102, 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 44309-2090, United States

Adena Regional Medical Center, Chillicothe, Ohio 45601, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States

Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, 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

Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States

Mercy Medical Center, Springfield, Ohio 45504, 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 19301-1792, 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 57117-5039, 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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2004
Last updated: December 1, 2012