Phase 2
N=91
Chemoprevention of Gastric Carcinogenesis
Gastric Cancer · Gastric Intestinal Metaplasia
Bottom Line
View on ClinicalTrials.gov: NCT02794428 ↗Enrolled (actual)
91
Serious AEs
4.4%
Results posted
Apr 2024
Primary outcome: Primary: The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months. — 5.07; 7.32 Percentage of positive cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eflornithine (Drug); Eflornithine placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months. |
5.07; 7.32 | — |
| SECONDARY The Difference in Cell DNA Damage Between Patients Treated With DFMO and Patients Treated With Placebo for 18 Months, and Then Followed for an Additional 6 Months. |
— | — |
| SECONDARY The Differences in the Gastritis Histopathology Score Between Patients Treated With DFMO and Patients Treated With Placebo for a Total of 18 Months, and Followed for an Additional 6 Months. |
— | — |
| SECONDARY Number of Patients With Quantitative Toxicities. |
— | — |
Summary
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
Eligibility Criteria
Inclusion Criteria
- Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
- Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
- Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
- Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL
- Kidney function: Creatinine 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV).
- Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for >5 years.
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.
Data sourced from ClinicalTrials.gov (NCT02794428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.