Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00006079
First received: August 3, 2000
Last updated: July 27, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006079

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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 July 20, 2014