Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00062010

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Biological: recombinant interferon alfa Drug: isotretinoin Drug: paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Interferon alfa-2a Interferon alfa-n1 Isotretinoin Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	83
Study Start Date:	February 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Recurrent disease
Prior chemotherapy for SCLC required
Clinically confirmed measurable disease

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 mg/dL
AST no greater than 2 times upper limit of normal (ULN)

Renal

Creatinine no greater than 1.5 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study treatment
Triglycerides no greater than 1.5 times ULN
No other prior malignancy except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy more than 5 years prior to study entry
No severe (≥ grade 2) depression requiring medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
No prior interferon alfa
No concurrent G-CSF or GM-CSF
Concurrent epoetin alfa allowed

Chemotherapy

See Disease Characteristics
More than 60 days since prior chemotherapy
No prior paclitaxel

Endocrine therapy

Not specified

Radiotherapy

More than 60 days since prior radiotherapy

Surgery

Not specified

Other

Recovered from prior therapy
More than 4 weeks since prior administration of any of the following drugs:
- Ethanol
- Tetracycline
- Doxycycline
- Minocycline
- Topical acne products (e.g., tretinoin-containing products)
- Vitamin A
- Carbamazepine
- Ketoconazole
- Phenytoin or other antiepileptic drugs
No concurrent vitamin supplements containing vitamin A during isotretinoin administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062010

Hide Study Locations

Locations

United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Columbus
Columbus, Ohio, United States, 43215
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Medical Center
Springfield, Ohio, United States, 45504
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Joseph Aisner, MD

Cancer Institute of New Jersey

Study ID Numbers:	CDR0000304430, ECOG-E6501
Study First Received:	June 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00062010 History of Changes
Health Authority:	United States: Federal Government