Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

NCT ID: NCT00009971

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fenretinide

Intervention Type: DRUG

Interventions

fenretinide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory P. Kalemkerian, MD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

CCUM-9940

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0112

Identifier Type: -

Identifier Source: secondary_id

CDR0000068428

Identifier Type: -

Identifier Source: org_study_id