search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interferon alpha
13-cis-retinoic acid
paclitaxel
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Rush-Copley Cancer Care Center
  • Hinsdale Hematology Oncology Associates
  • Joliet Oncology-Hematology Associates, Limited - West
  • Swedish-American Regional Cancer Center
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Anthony Memorial Health Centers
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • Mercy Capitol Hospital
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • McCreery Cancer Center at Ottumwa Regional
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Duluth Clinic Cancer Center - Duluth
  • CCOP - Duluth
  • Miller - Dwan Medical Center
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • HealthEast Cancer Care at St. John's Hospital
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • Regions Hospital Cancer Care Center
  • HealthEast Cancer Care at St. Joseph's Hospital
  • St. Francis Cancer Center at St. Francis Medical Center
  • HealthEast Cancer Care at Woodwinds Health Campus
  • Cancer Resource Center - Lincoln
  • CCOP - Missouri Valley Cancer Consortium
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Hunterdon Regional Cancer Center at Hunterdon Medical Center
  • CCOP - Northern New Jersey
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Akron City Hospital
  • Adena Regional Medical Center
  • Case Comprehensive Cancer Center
  • MetroHealth Cancer Care Center at MetroHealth Medical Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Fairfield Medical Center
  • St. Rita's Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Mount Carmel St. Ann's Cancer Center
  • Genesis - Good Samaritan Hospital
  • Bryn Mawr Hospital
  • Cancer Center of Paoli Memorial Hospital
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sanford Cancer Center at Sanford USD Medical Center
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IFN-alpha, 13-CRA, paclitaxel

Arm Description

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

Outcomes

Primary Outcome Measures

Response by RECIST Criteria (v 1.0)
Number of eligible, treated participants in each response category by RECIST criteria

Secondary Outcome Measures

Survival
Time from registration to death.
Progression-free Survival
Time from registration to documented disease progression (RECIST criteria) or death.

Full Information

First Posted
June 5, 2003
Last Updated
June 21, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00062010
Brief Title
Interferon Alfa, Isotretinoin, and Paclitaxel 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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2004 (Actual)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IFN-alpha, 13-CRA, paclitaxel
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
interferon alpha
Other Intervention Name(s)
Interferon Alpha-2b, Intron-A, IFN-alpha 2b, NSC# 377523
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
13-cis-retinoic acid
Other Intervention Name(s)
Isotretinoin, RO-43,780, Accutane, Cistane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol, NSC #125973
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response by RECIST Criteria (v 1.0)
Description
Number of eligible, treated participants in each response category by RECIST criteria
Time Frame
Assessed every 6 weeks
Secondary Outcome Measure Information:
Title
Survival
Description
Time from registration to death.
Time Frame
Assessed every 3 months for 1 year then every 6 months
Title
Progression-free Survival
Description
Time from registration to documented disease progression (RECIST criteria) or death.
Time Frame
Assessed every 6 weeks

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs