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
5 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 1998
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 1998
CompletedFirst Submitted
Initial submission to the registry
August 3, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2004
CompletedFirst Posted
Study publicly available on registry
May 26, 2004
CompletedOctober 25, 2018
October 1, 2018
5.9 years
August 3, 2000
October 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy Comparison of Eflornithine versus Placebo
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.
28 Days
Study Arms (3)
Arm I
EXPERIMENTALArm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
Arm II
EXPERIMENTALArm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.
Arm III
PLACEBO COMPARATORArm III: Patients receive oral placebo daily. Treatment continues for 28 days.
Interventions
Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
Eligibility Criteria
You may qualify if:
- \) 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
You may not qualify if:
- \) Patients may not have had a prior malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michele Follen, MD, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2000
First Posted
May 26, 2004
Study Start
June 19, 1998
Primary Completion
April 27, 2004
Study Completion
April 27, 2004
Last Updated
October 25, 2018
Record last verified: 2018-10