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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003075 |
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/Nonmalignant Condition |
Drug: fenretinide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 1992 |
OBJECTIVES: I. Determine the efficacy of femretinide (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 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 |
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| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Michele Follen, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065761, MDA-ID-92027, NCI-P97-0092 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003075 History of Changes |
| Health Authority: | United States: Federal Government |
|
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
|
Anticarcinogenic Agents Precancerous Conditions Carcinoma in Situ Fenretinide |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
|
Anticarcinogenic Agents Neoplasms by Histologic Type Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Protective Agents Pharmacologic Actions |
Cervical Intraepithelial Neoplasia Carcinoma Neoplasms Carcinoma in Situ Therapeutic Uses Fenretinide Neoplasms, Glandular and Epithelial |
