Eflornithine plus sulindac for Colorectal Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Colorectal CancerEflornithine plus sulindac - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a combination of drugs to see if they are effective in reducing the chance of cancer recurrence or developing new cancers.

Eligible Conditions
  • Colorectal Cancer

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to 8 years

3 years after registration
Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)
Year 8
Time to first clinically apparent high-risk adenoma or second primary CRC
Up to 3 years
Baseline meat consumption
Baseline statin use
PK analysis
Toxicity
Type of cancer at baseline: colorectal vs rectal
Year 3
Biomarker identification based on Integrated Comprehensive Droplet Digital Detection technology
Up to 8 years
Adenomas >= 1 cm
Adenoma
Colon cancer recurrence
High-grade dysplasia
Multiple adenomas, defined as 3 or more adenomas all measuring > 0.3 cm
The number of patients with development of any adenoma > 0.3 cm
Total advanced colorectal event rate, defined as the number of patients with at least one high risk adenoma, second primary CRC, CRC recurrence, or metastasis
Adenoma

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Eflornithine & sulindac placebo
1 of 4
Eflornithine placebo & sulindac
1 of 4
Eflornithine plus sulindac
1 of 4
eflornithine placebo & sulindac placebo
1 of 4

Experimental Treatment

Non-Treatment Group

1340 Total Participants · 4 Treatment Groups

Primary Treatment: Eflornithine plus sulindac · Has Placebo Group · Phase 3

Eflornithine & sulindac placebo
Drug
Experimental Group · 1 Intervention: eflornithine & sulindac placebo · Intervention Types: Drug
Eflornithine placebo & sulindac
Drug
Experimental Group · 1 Intervention: Eflornithine placebo & sulindac · Intervention Types: Drug
Eflornithine plus sulindac
Drug
Experimental Group · 1 Intervention: Eflornithine plus sulindac · Intervention Types: Drug
eflornithine placebo & sulindac placebo
Drug
PlaceboComparator Group · 1 Intervention: Eflornithine placebo & sulindac placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
386 Previous Clinical Trials
260,313 Total Patients Enrolled
Cancer Prevention Pharmaceuticals, Inc.Industry Sponsor
7 Previous Clinical Trials
442 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,127,515 Total Patients Enrolled
Jason A. Zell, D.O., MPHPrincipal InvestigatorUniversity of California, Irvine

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease.
You have completed adjuvant chemo and RT.
Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis.
Presence of gastroesophageal reflux disease acceptable if controlled with medications.
You have a white blood cell count ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin ≥ 11.0 g/dL

Who else is applying?

What state do they live in?
North Carolina50.0%
Minnesota50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hennepin County Medical Center50.0%
Southeastern Medical Oncology Center-Goldsboro50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Hennepin County Medical Center: < 24 hours
  2. Southeastern Medical Oncology Center-Goldsboro: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email50.0%
Phone Call50.0%