Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00062010
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IFN-alpha, 13-CRA, paclitaxel interferon alpha 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 IFN-alpha, 13-CRA, paclitaxel 13-cis-retinoic acid 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 IFN-alpha, 13-CRA, paclitaxel 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
- Primary Outcome Measures
Name Time Method Response by RECIST Criteria (v 1.0) Assessed every 6 weeks Number of eligible, treated participants in each response category by RECIST criteria
- Secondary Outcome Measures
Name Time Method Progression-free Survival Assessed every 6 weeks Time from registration to documented disease progression (RECIST criteria) or death.
Survival Assessed every 3 months for 1 year then every 6 months Time from registration to death.
Trial Locations
- Locations (73)
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Swedish-American Regional Cancer Center
🇺🇸Rockford, Illinois, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States