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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | November 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00009971 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer | ||||
| Official Title ICMJE | Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer | ||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Drug: fenretinide | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00009971 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068428, CCUM-9940, NCI-T99-0112 | ||||
| Study Sponsor ICMJE | University of Michigan Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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