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

February 2, 2001
July 23, 2008
November 2000
 
 
 
Complete list of historical versions of study NCT00009971 on ClinicalTrials.gov Archive Site
 
 
 
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer

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

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.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
Drug: fenretinide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009971
 
CDR0000068428, CCUM-9940, NCI-T99-0112
University of Michigan Cancer Center
National Cancer Institute (NCI)
Study Chair: Gregory P. Kalemkerian, MD University of Michigan Cancer Center
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP