Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Phase 2

Completed

• Conditions: Cervical Cancer; Precancerous Condition
• Interventions: Other: Placebo; Drug: Eflornithine

• Registration Number: NCT00006079
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 1998-06-19
• Study First Submitted: 2000-08-03
• Primary Completion: 2004-04-27
• Study Completion: 2004-04-27
• Study First Submitted QC: 2004-05-25
• Study First Posted: 2004-05-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm III	Placebo	Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.
Arm I	Eflornithine	Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
Arm II	Eflornithine	Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

Primary Outcome Measures

Name	Time	Method
Efficacy Comparison of Eflornithine versus Placebo	28 Days	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.

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States