Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
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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 Condition |
Drug: Eflornithine Other: Placebo |
Phase 2 |
| 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 Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3 |
- Efficacy Comparison of Eflornithine versus Placebo [ Time Frame: 28 Days ] [ Designated as safety issue: No ]Efficacy in causing regression in patients with cervical intraepithelial neoplasia measured by absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.
| Enrollment: | 150 |
| Study Start Date: | June 2000 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
|
Drug: Eflornithine
Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
|
|
Experimental: Arm II
Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
|
Drug: Eflornithine
Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
|
|
Placebo Comparator: Arm III
Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.
|
Other: Placebo
Patients receive oral placebo daily for 28 days.
|
Detailed Description:
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 |
Inclusion Criteria:
1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger than the biopsy site. Patients must be > 18 years old, with a performance status less than or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12 months. Patients must have a medically safe form of contraception for the duration of the study. All patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation
Exclusion Criteria:
1) Patients may not have had a prior malignancy.
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
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006079 History of Changes |
| Other Study ID Numbers: | ID92-026, P30CA016672, MDA-ID-92026, NCI-P00-0149, CDR0000067921 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Federal Government 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 Eflornithine |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Eflornithine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013