Fenretinide in Treating Patients With Cervical Neoplasia

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00003075

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

97.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cervical Cancer Precancerous Condition	Drug: Fenretinide Other: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, 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

Actual Study Start Date :

Mar 5, 1993

Actual Primary Completion Date :

May 1, 2001

Actual Study Completion Date :

May 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fenretinide	Drug: Fenretinide Oral Fenretinide daily for 6 months with 3 days of rest every month. Other Names: 4-HPR
Placebo Comparator: Placebo	Other: Placebo Oral placebo daily for 6 months with 3 days of rest every month.

Arm

Intervention/Treatment

Experimental: Fenretinide

Drug: Fenretinide

Oral Fenretinide daily for 6 months with 3 days of rest every month.

Other Names:

4-HPR

Placebo Comparator: Placebo

Other: Placebo

Oral placebo daily for 6 months with 3 days of rest every month.

Outcome Measures

Primary Outcome Measures

Efficacy of Fenretinide at Regressing CIN [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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