A Phase 2 interventional study of Eflornithine and Placebo in Cervical Cancer and Precancerous Condition, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Prevention
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.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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.
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. Treatment continues for 28 days.
Drug: Eflornithine
Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.
Other: Placebo
Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
Patients receive oral placebo daily for 28 days.
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.
Time frame: 28 Days
Ran from Jun 1998 to primary completion in Apr 2004, 70 months.
Of 132 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 102. This study's 70 months is above that.
Counting every sponsor, half of 173 studies reached it within 42 months; a quarter within 29 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eflornithine