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Fenretinide in Treating Patients With Cervical Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00003075
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012

November 1, 1999
July 27, 2012
September 1992
September 2000   (final data collection date for primary outcome measure)
Efficacy of Fenretinide at Regressing CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003075 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Fenretinide in Treating Patients With Cervical Neoplasia
A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia.

OBJECTIVES: I. Determine the efficacy of fenretinide (N-(4-hydroxyphenyl) retinamide; 4-HPR) at regressing cervical intraepithelial neoplasia (CIN). II. Document the qualitative and quantitative toxicity of 4-HPR in women with CIN.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Precancerous Condition
  • Drug: Fenretinide
    Oral Fenretinide daily for 6 months with 3 days of rest every month.
    Other Name: 4-HPR
  • Other: Placebo
    Oral placebo daily for 6 months with 3 days of rest every month.
  • Experimental: Fenretinide
    Intervention: Drug: Fenretinide
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2001
September 2000   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003075
ID92-027, P30CA016672, MDA-ID-92027, NCI-P97-0092, CDR0000065761
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Michele Follen, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP