Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003151
• Other study ID #: EORTC-20961
• Secondary ID: EORTC-20961CRC-E
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: September 1997

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.

PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.

Description:

OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission rate after eradication of Helicobacter pylori in this patient population. III. Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.

OUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10. Patients are evaluated at 8 weeks. Patients who experience complete remission and are H. pylori negative proceed to follow up. Patients with complete remission or no change but who are H. pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.

PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: October 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven, previously untreated, low grade gastric lymphoma Clinical stage I and II1 No bulky disease No high grade component (grade 5 and 4, if monoclonality proven, allowed) Documented presence/absence of H. pylori infection Measurable and/or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception No prior or concurrent malignancies unless: At least 1 year remission Low risk or recurrence No prior gastric malignancy No nonmalignant disease causing poor medical risk No allergy to omeprazole

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the abdomen Surgery: No prior gastric surgery except simple closure of perforated ulcer with or without wedge excision of the ulcer Other: No prior therapy for gastric lymphoma At least 30 days since experimental therapy No other concurrent experimental therapy At least 30 days since antibiotics with activity against H. pylori

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Dietary Supplement:
• bismuth subcitrate

Drug:
• amoxicillin

• clarithromycin

• metronidazole hydrochloride

• omeprazole

• tetracycline hydrochloride

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	University Birmingham N.H.S. Trust	Birmingham	England
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Royal Infirmary	Glasgow	Scotland
United Kingdom	Royal Free Hospital	Hampstead, London	England
United Kingdom	St. James's Hospital	Leeds	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's, King's and St. Thomas' Hospitals Trust	London	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Royal Free Hospital School of Medicine	London	England
United Kingdom	Royal Marsden NHS Trust	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Royal South Hants Hospital	Southampton	England
United Kingdom	Royal Marsden Hospital	Sutton	England

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	University of Glasgow

Country where clinical trial is conducted

United Kingdom,