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CompletedNCT00009971Updated Feb 11, 2013

Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

A Phase 2 interventional study of fenretinide in Lung Cancer, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

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.

02

Conditions studied

  • Lung Cancer

Keywords

  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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:

Chemotherapy:

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

Endocrine therapy:

  • Concurrent steroids allowed at stable dose

Radiotherapy:

  • No prior radiotherapy to study lesions

Other:

  • At least 3 weeks since prior systemic retinoid or carotenoid therapy
  • No concurrent anticonvulsants
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

Interventions

  • Drugfenretinide
06

Study locations

2 sites
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0752, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00009971
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Nov 2000
Primary completion
Sep 2005
Last update
Feb 11, 2013

Study contacts

Gregory P. Kalemkerian, MD
study chair · University of Michigan Rogel Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2003. You cannot join it, but the record below documents what was studied.

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