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

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ClinicalTrials.gov Identifier: NCT00062010
Recruitment Status : Completed
First Posted : June 6, 2003
Results First Posted : January 4, 2013
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: interferon alpha Drug: 13-cis-retinoic acid Drug: paclitaxel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
Study Start Date : February 2004
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2012


Arm Intervention/treatment
Experimental: IFN-alpha, 13-CRA, paclitaxel
Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle
Biological: interferon alpha
Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
  • Interferon Alpha-2b
  • Intron-A
  • IFN-alpha 2b
  • NSC# 377523

Drug: 13-cis-retinoic acid
13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
  • Isotretinoin
  • RO-43,780
  • Accutane
  • Cistane

Drug: paclitaxel
paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
  • Taxol
  • NSC #125973




Primary Outcome Measures :
  1. Response by RECIST Criteria (v 1.0) [ Time Frame: Assessed every 6 weeks ]
    Number of eligible, treated participants in each response category by RECIST criteria


Secondary Outcome Measures :
  1. Survival [ Time Frame: Assessed every 3 months for 1 year then every 6 months ]
    Time from registration to death.

  2. Progression-free Survival [ Time Frame: Assessed every 6 weeks ]
    Time from registration to documented disease progression (RECIST criteria) or death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062010


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

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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00062010     History of Changes
Other Study ID Numbers: CDR0000304430
E6501 ( Other Identifier: ECOG )
First Posted: June 6, 2003    Key Record Dates
Results First Posted: January 4, 2013
Last Update Posted: October 8, 2015
Last Verified: December 2012
Keywords provided by Eastern Cooperative Oncology Group:
recurrent small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Interferons
Interferon-alpha
Interferon alpha-2
Paclitaxel
Albumin-Bound Paclitaxel
Tretinoin
Isotretinoin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents