Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Other: Placebo; Drug: Eflornithine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006079

P30CA016672 (U.S. NIH Grant/Contract)

MDA-ID-92026 (Other Identifier)

ID92-026

NCI-P00-0149

CDR0000067921 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Arm I

Experimental group

Description:

Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

Treatment:

Drug: Eflornithine

Arm II

Experimental group

Description:

Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

Treatment:

Drug: Eflornithine

Arm III

Placebo Comparator group

Description:

Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.

Treatment:

Other: Placebo