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Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
This study has been completed.

First Received on June 5, 2003.   Last Updated on January 27, 2010   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00062010
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: recombinant interferon alfa
Drug: isotretinoin
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 83
Study Start Date: February 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062010

  Show 73 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Joseph Aisner, MD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00062010     History of Changes
Other Study ID Numbers: CDR0000304430, E6501
Study First Received: June 5, 2003
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Interferon-alpha
Interferon Alfa-2a
Interferons
Paclitaxel
Isotretinoin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Dermatologic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 12, 2012