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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.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Drug: isotretinoin
Drug: paclitaxel
Drug: recombinant interferon alfa
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Paclitaxel    Isotretinoin    Tretinoin    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

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

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  Show 73 Study Locations

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Joseph Aisner, MD     Cancer Institute of New Jersey    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000304430, ECOG-E6501
First Received:   June 5, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00062010
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer  

Study placed in the following topic categories:
Interferon-alpha
Thoracic Neoplasms
Interferon Type I, Recombinant
Carcinoma, Neuroendocrine
Interferons
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Isotretinoin
Tretinoin
Neuroepithelioma
Interferon Alfa-2a
Adenocarcinoma
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antimitotic Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2008




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