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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00009971 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: fenretinide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer |
| Study Start Date: | November 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 11-16 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy
Measurable disease
No symptomatic or uncontrolled brain or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| Study Chair: | Gregory P. Kalemkerian, MD | University of Michigan Cancer Center |
More Information
| Study ID Numbers: | CDR0000068428, CCUM-9940, NCI-T99-0112 |
| Study First Received: | February 2, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00009971 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer |
|
Anticarcinogenic Agents Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Protective Agents Pharmacologic Actions Carcinoma Neuroendocrine Tumors |
Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasms, Germ Cell and Embryonal Fenretinide Adenocarcinoma Neoplasms, Glandular and Epithelial |