Clinical trial NCT00009971: Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Official title: Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: limited stage small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Gregory P. Kalemkerian, MD
role: STUDY_CHAIR
References: