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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

August 3, 2000
July 27, 2012
June 2000
February 2003   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00006079 on ClinicalTrials.gov Archive Site
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Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Precancerous Condition
  • Drug: Eflornithine
    Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
  • Other: Placebo
    Patients receive oral placebo daily for 28 days.
  • Experimental: Arm I
    Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
    Intervention: Drug: Eflornithine
  • Experimental: Arm II
    Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
    Intervention: Drug: Eflornithine
  • Placebo Comparator: Arm III
    Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2004
February 2003   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006079
ID92-026, P30CA016672, MDA-ID-92026, NCI-P00-0149, CDR0000067921
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Michele Follen, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP