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
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Drug: Fenretinide
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy of Fenretinide at Regressing CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 1992
Study Completion Date: May 2001
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenretinide Drug: Fenretinide
Oral Fenretinide daily for 6 months with 3 days of rest every month.
Other Name: 4-HPR
Placebo Comparator: Placebo Other: Placebo
Oral placebo daily for 6 months with 3 days of rest every month.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003075

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michele Follen, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003075     History of Changes
Other Study ID Numbers: ID92-027, P30CA016672, MDA-ID-92027, NCI-P97-0092, CDR0000065761
Study First Received: November 1, 1999
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 29, 2014