Fenretinide in Treating Patients With Cervical Neoplasia
NCT ID: NCT00003075
Last Updated: 2018-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
39 participants
INTERVENTIONAL
1993-03-05
2001-05-01
Brief Summary
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PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia.
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Detailed Description
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OUTLINE: This is a double blinded study. Patients are randomized to receive either fenretinide or placebo. Patients are administered fenretinide or a placebo by mouth (PO) daily for 6 months with 3 days of rest every month. Patients undergo colposcopy, colpophotography, and Pap smears at 3, 6, 9, and 12 months. Patients undergo cervical biopsy at 6 and 12 months to assess changes.
PROJECTED ACCRUAL: 84-100 patients will be accrued.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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Fenretinide
Fenretinide
Oral Fenretinide daily for 6 months with 3 days of rest every month.
Placebo
Placebo
Oral placebo daily for 6 months with 3 days of rest every month.
Interventions
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Fenretinide
Oral Fenretinide daily for 6 months with 3 days of rest every month.
Placebo
Oral placebo daily for 6 months with 3 days of rest every month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective contraception Fasting triglyceride less than 2 times normal No prior malignancy Must consent to colposcopy and cervical biopsy
PRIOR CONCURRENT THERAPY: Not specified
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michele Follen, MD, PhD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-92027
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P97-0092
Identifier Type: -
Identifier Source: secondary_id
CDR0000065761
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID92-027
Identifier Type: -
Identifier Source: org_study_id
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