Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 1269 for:    IFNA2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Biological: interferon alpha
Drug: 13-cis-retinoic acid
Drug: paclitaxel
Enrollment 37
Recruitment Details Participants were recruited from ECOG member institutions between February 24, 2004 and August 22, 2007.
Pre-assignment Details  
Arm/Group Title IFN Alpha, 13-Cis-RA, Paclitaxel
Hide Arm/Group Description Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Period Title: Overall Study
Started 37
Eligible and Treated 34
Completed 34
Not Completed 3
Reason Not Completed
Ineligible             3
Arm/Group Title IFN 13CRA Paclitaxel
Hide Arm/Group Description Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  76.5%
>=65 years
8
  23.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
60
(39 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
12
  35.3%
Male
22
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Response by RECIST Criteria (v 1.0)
Hide Description Number of eligible, treated participants in each response category by RECIST criteria
Time Frame Assessed every 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, treated patients
Arm/Group Title IFN 13CRA Paclitaxel
Hide Arm/Group Description:
Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
Partial Response 3
Stable Disease 5
Progressive Disease 11
Unevaluable 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN 13CRA Paclitaxel
Comments The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall Response Percentage
Estimated Value 8.8
Confidence Interval (2-Sided) 90%
2.4 to 21.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Survival
Hide Description Time from registration to death.
Time Frame Assessed every 3 months for 1 year then every 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, treated patients
Arm/Group Title IFN 13CRA Paclitaxel
Hide Arm/Group Description:
Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(4.7 to 9.8)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Time from registration to documented disease progression (RECIST criteria) or death.
Time Frame Assessed every 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, treated patients
Arm/Group Title IFN 13CRA Paclitaxel
Hide Arm/Group Description:
Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.8 to 3.9)
Time Frame Assessed weekly during treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IFN Alpha, 13-CRA, Paclitaxel
Hide Arm/Group Description Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
All-Cause Mortality
IFN Alpha, 13-CRA, Paclitaxel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IFN Alpha, 13-CRA, Paclitaxel
Affected / at Risk (%)
Total   21/34 (61.76%) 
Blood and lymphatic system disorders   
Leukopenia  1  11/34 (32.35%) 
Neutropenia  1  8/34 (23.53%) 
Transfusion-Red Blood Cells  1  2/34 (5.88%) 
Gastrointestinal disorders   
Dysphagia  1  1/34 (2.94%) 
Pancreatitis  1  1/34 (2.94%) 
Vomiting  1  1/34 (2.94%) 
General disorders   
Fatigue  1  7/34 (20.59%) 
Infections and infestations   
Infection with Grade 3 or 4 Neutropenia  1  1/34 (2.94%) 
Infection without Neutropenia  1  1/34 (2.94%) 
Investigations   
Alkaline Phosphatase Increased  1  1/34 (2.94%) 
AST Increased  1  1/34 (2.94%) 
ALT Increased  1  1/34 (2.94%) 
Febrile Neutropenia  1  1/34 (2.94%) 
Amylase Increased  1  1/34 (2.94%) 
Lipase Increased  1  1/34 (2.94%) 
Metabolism and nutrition disorders   
Dehydration  1  2/34 (5.88%) 
Hypertriglyceridemia  1  4/34 (11.76%) 
Hypokalemia  1  2/34 (5.88%) 
Hyponatremia  1  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1  2/34 (5.88%) 
Nervous system disorders   
"Neuropathy, Motor"  1  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/34 (2.94%) 
Dyspnea  1  1/34 (2.94%) 
Vascular disorders   
Hypotension  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI CTCAE Version 2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IFN Alpha, 13-CRA, Paclitaxel
Affected / at Risk (%)
Total   33/34 (97.06%) 
Blood and lymphatic system disorders   
Lymphopenia  1  2/34 (5.88%) 
Thrombocytopenia  1  13/34 (38.24%) 
Gastrointestinal disorders   
Constipation  1  2/34 (5.88%) 
Dyspepsia  1  2/34 (5.88%) 
Mouth Dryness  1  5/34 (14.71%) 
Nausea  1  8/34 (23.53%) 
Stomatitis  1  4/34 (11.76%) 
Diarrhea  1  4/34 (11.76%) 
Pain, Abdominal  1  2/34 (5.88%) 
General disorders   
Edema  1  4/34 (11.76%) 
Fever  1  7/34 (20.59%) 
Rigors/Chills  1  14/34 (41.18%) 
Constitutional  1  2/34 (5.88%) 
Pain, Other  1  2/34 (5.88%) 
Investigations   
Weight Loss  1  6/34 (17.65%) 
Prothrombin Time Increased  1  2/34 (5.88%) 
Bilirubin Increased  1  5/34 (14.71%) 
Creatinine Increased  1  3/34 (8.82%) 
Metabolism and nutrition disorders   
Anorexia  1  12/34 (35.29%) 
Hyperglycemia  1  2/34 (5.88%) 
Hypomagnesemia  1  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  11/34 (32.35%) 
Pain, Bone  1  2/34 (5.88%) 
Myalgia  1  5/34 (14.71%) 
Nervous system disorders   
Taste Disturbance  1  6/34 (17.65%) 
Dizziness/Lightheadedness  1  4/34 (11.76%) 
Neuropathy, Sensory  1  11/34 (32.35%) 
Headache  1  6/34 (17.65%) 
Psychiatric disorders   
Confusion  1  2/34 (5.88%) 
Insomnia  1  3/34 (8.82%) 
Depression  1  4/34 (11.76%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  2/34 (5.88%) 
Skin and subcutaneous tissue disorders   
Sweating  1  2/34 (5.88%) 
Alopecia  1  11/34 (32.35%) 
Dry Skin  1  5/34 (14.71%) 
Pruritus  1  3/34 (8.82%) 
Rash/Desquamation  1  3/34 (8.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI CTCAE Version 2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00062010     History of Changes
Other Study ID Numbers: CDR0000304430
E6501 ( Other Identifier: ECOG )
First Submitted: June 5, 2003
First Posted: June 6, 2003
Results First Submitted: December 1, 2012
Results First Posted: January 4, 2013
Last Update Posted: October 8, 2015