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A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Efficacy Comparison of Eflornithine versus Placebo

Outcome Description:

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.

Outcome Time Frame:

28 Days

Safety Issue:

No

Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

ID92-026

NCT ID:

NCT00006079

Start Date:

June 2000

Completion Date:

April 2004

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Eflornithine
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009