Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009971
• Other study ID #: CDR0000068428
• Secondary ID: CCUM-9940NCI-T99
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: February 8, 2013
• Start date: November 2000

Study information

• Verified date: October 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• fenretinide

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,