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Trial record 93 of 1273 for:    IFNA2

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

Tracking Information
First Submitted Date  ICMJE June 5, 2003
First Posted Date  ICMJE June 6, 2003
Results First Submitted Date  ICMJE December 1, 2012
Results First Posted Date  ICMJE January 4, 2013
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE February 2004
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2012)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00062010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2012)
  • Survival [ Time Frame: Assessed every 3 months for 1 year then every 6 months ]
    Time from registration to death.
  • Progression-free Survival [ Time Frame: Assessed every 6 weeks ]
    Time from registration to documented disease progression (RECIST criteria) or death.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Official Title  ICMJE Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Biological: interferon alpha
  • Drug: 13-cis-retinoic acid
  • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2012)
37
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00062010
Other Study ID Numbers  ICMJE CDR0000304430
E6501 ( Other Identifier: ECOG )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eastern Cooperative Oncology Group
Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Joseph Aisner, MD Rutgers Cancer Institute of New Jersey
PRS Account Eastern Cooperative Oncology Group
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP