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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: | NCT00006079 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Precancerous/Nonmalignant Condition |
Drug: eflornithine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3 |
| Study Start Date: | June 2000 |
OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. II. Compare the qualitative and quantitative toxicities of these treatment regimens in these patients. III. Establish the biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed or recurrent cervical intraepithelial neoplasia grade 2-3 Involves area 3 times larger than the biopsy site (4-6 mm2 lesion)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fertile patients must use effective contraception No prior malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: 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: | CDR0000067921, MDA-ID-92026, NCI-P00-0149 |
| Study First Received: | August 3, 2000 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006079 History of Changes |
| Health Authority: | United States: Federal Government |
|
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
|
Precancerous Conditions Eflornithine Carcinoma in Situ |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
|
Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Neoplasms by Histologic Type Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Pharmacologic Actions |
Cervical Intraepithelial Neoplasia Carcinoma Antiparasitic Agents Neoplasms Eflornithine Carcinoma in Situ Therapeutic Uses Neoplasms, Glandular and Epithelial |
