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Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: February 2, 2001
Last updated: February 8, 2013
Last verified: October 2003
Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition Intervention Phase
Lung Cancer
Drug: fenretinide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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):

Enrollment: 32
Study Start Date: November 2000
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Drug: fenretinide

Detailed Description:


I. 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.

II. Determine the toxicity of this regimen in these patients. III. 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod 0-2


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


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


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


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


  • 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



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

Endocrine therapy:

  • Concurrent steroids allowed at stable dose


  • No prior radiotherapy to study lesions


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

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

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00009971     History of Changes
Other Study ID Numbers: CDR0000068428
Study First Received: February 2, 2001
Last Updated: February 8, 2013

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:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on May 23, 2017