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Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
This study has been completed.
First Received: February 2, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: University of Michigan Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009971
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer


Condition Intervention Phase
Lung Cancer
Drug: fenretinide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer

Resource links provided by NLM:


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

Study Start Date: November 2000
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer.
  • Determine the toxicity of this regimen in these patients.
  • Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 11-16 months.

  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 recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy

    • Limited stage or extensive stage SCLC
  • Measurable disease

    • At least 20 mm by conventional techniques OR
    • At least 10 mm with spiral CT scan
  • No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease
  • No symptomatic or uncontrolled brain or leptomeningeal disease

    • Previously treated brain metastases allowed if neurologically stable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,500/mm^3
  • Platelet count at least 70,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic heart disease
  • No myocardial infarction within the past 6 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study
  • No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders)
  • No other serious concurrent illness
  • No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens

Endocrine therapy:

  • Concurrent steroids allowed at stable dose

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to study lesions

Surgery:

  • Not specified

Other:

  • At least 3 weeks since prior systemic retinoid or carotenoid therapy
  • No concurrent anticonvulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009971

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Gregory P. Kalemkerian, MD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068428, CCUM-9940, NCI-T99-0112
Study First Received: February 2, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00009971     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anticarcinogenic Agents
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Protective Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Fenretinide
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009