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Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gregory P. Kalemkerian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068428

NCT ID:

NCT00009971

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201