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Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00062010   Information provided by National Cancer Institute (NCI)
First Received: June 5, 2003   Last Updated: February 6, 2009   History of Changes

June 5, 2003
February 6, 2009
February 2004
 
Objective response [ Designated as safety issue: No ]
Objective response
Complete list of historical versions of study NCT00062010 on ClinicalTrials.gov Archive Site
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Duration of response
  • Survival
 
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

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.

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.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
  • Biological: recombinant interferon alfa
  • Drug: isotretinoin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
83
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)

    • Recurrent disease
  • Prior chemotherapy for SCLC required
  • Clinically confirmed measurable disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • AST no greater than 2 times upper limit of normal (ULN)

Renal

  • Creatinine no greater than 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study treatment
  • Triglycerides no greater than 1.5 times ULN
  • No other prior malignancy except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy more than 5 years prior to study entry
  • No severe (≥ grade 2) depression requiring medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No prior interferon alfa
  • No concurrent G-CSF or GM-CSF
  • Concurrent epoetin alfa allowed

Chemotherapy

  • See Disease Characteristics
  • More than 60 days since prior chemotherapy
  • No prior paclitaxel

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 60 days since prior radiotherapy

Surgery

  • Not specified

Other

  • Recovered from prior therapy
  • More than 4 weeks since prior administration of any of the following drugs:

    • Ethanol
    • Tetracycline
    • Doxycycline
    • Minocycline
    • Topical acne products (e.g., tretinoin-containing products)
    • Vitamin A
    • Carbamazepine
    • Ketoconazole
    • Phenytoin or other antiepileptic drugs
  • No concurrent vitamin supplements containing vitamin A during isotretinoin administration
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062010
 
CDR0000304430, ECOG-E6501
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Joseph Aisner, MD Cancer Institute of New Jersey
National Cancer Institute (NCI)
September 2007

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