NCT00009971

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

February 11, 2013

Status Verified

October 1, 2003

Enrollment Period

4.8 years

First QC Date

February 2, 2001

Last Update Submit

February 8, 2013

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: fenretinide

Interventions

fenretinideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Gregory P. Kalemkerian, MD

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

November 1, 2000

Primary Completion

September 1, 2005

Last Updated

February 11, 2013

Record last verified: 2003-10

Locations

US(2)