Chemoprevention of Gastric Carcinogenesis

NCT02794428 | Completed Phase 2 Results DMC

• 2 other identifiers: VICC GI 15276R01CA190612-03
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Gastric Cancer; Gastric Intestinal Metaplasia

Keywords

Gastric adenocarcinoma; Gastric intestinal metaplasia; Atrophic gastritis; Gastric premalignant lesion

Outcome Measures

Primary Outcomes (1)

• The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.

  The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX.The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.

  at 6 months

Secondary Outcomes (3)

• 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.

  at 18 and 24 months

• 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.

  at 6, 18 and 24 months

• Number of Patients With Quantitative Toxicities.

  at 6, 18, and 24 months

Study Arms (2)

Eflornithine

ACTIVE COMPARATOR

Drug: Eflornithine

Eflornithine Placebo

PLACEBO COMPARATOR

Other: Eflornithine placebo

Interventions

Eflornithine DRUG

Eflornithine\*, 2 tablets, Oral, Daily for 18 months

Eflornithine

Eflornithine placebo OTHER

Eflornithine placebo, 2 tablets, Oral, Daily for 18 months

Eflornithine Placebo

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<1.6 x IULN (institutional upper limit of normal)
• Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN

You may not qualify if:

• Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
• Patients must not have a significant medical or psychiatric condition that would preclude study completion.
• Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
• Patients must not have known hypersensitivity to eflornithine or the excipients.
• Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
• Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP \> 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Cancer Prevention Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Ministry of Health, Hospital de Occidente

Copán, Honduras

Location

University of Puerto Rico, Comprehensive Cancer Center

San Juan, Puerto Rico

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Results Point of Contact

• Title: Douglas Morgan
• Organization: Vanderbilt-Ingram Cancer Center

drmorgan@uabmc.edu

615-936-7423

Study Officials

• Doug Morgan, MD

  Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter

  STUDY CHAIR

• Keith Wilson, MD

  Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Latin America sites, Vanderbilt Institute for Global Health

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 9, 2016
• Study Start: September 19, 2016
• Primary Completion: December 20, 2022
• Study Completion: July 1, 2024
• Last Updated: October 16, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1); PR (1)