Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
2 other identifiers
interventional
37
1 country
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 lung-cancer
Started May 2004
Longer than P75 for phase_2 lung-cancer
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2003
CompletedFirst Posted
Study publicly available on registry
June 6, 2003
CompletedStudy Start
First participant enrolled
May 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 4, 2013
CompletedJuly 7, 2023
June 1, 2023
6.9 years
June 5, 2003
December 1, 2012
June 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response by RECIST Criteria (v 1.0)
Number of eligible, treated participants in each response category by RECIST criteria
Assessed every 6 weeks
Secondary Outcomes (2)
Survival
Assessed every 3 months for 1 year then every 6 months
Progression-free Survival
Assessed every 6 weeks
Study Arms (1)
IFN-alpha, 13-CRA, paclitaxel
EXPERIMENTALInterferon 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
Interventions
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
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
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, 49007-3731, 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, 55805-1983, 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
The 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
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, 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, 19301-1792, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Joseph Aisner, MD
Rutgers Cancer Institute of New Jersey
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2003
First Posted
June 6, 2003
Study Start
May 26, 2004
Primary Completion
May 1, 2011
Study Completion
August 1, 2012
Last Updated
July 7, 2023
Results First Posted
January 4, 2013
Record last verified: 2023-06