Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00003151

Collaborator

University of Glasgow (Other)

Enrollment

Locations

4.4

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Dietary Supplement: bismuth subcitrate Drug: amoxicillin Drug: clarithromycin Drug: metronidazole hydrochloride Drug: omeprazole Drug: tetracycline hydrochloride	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1997

Actual Primary Completion Date :

Oct 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal United Hospital	Bath	England	United Kingdom	BA1 3NG
2	University Birmingham N.H.S. Trust	Birmingham	England	United Kingdom	B15 2TA
3	Royal Free Hospital	Hampstead, London	England	United Kingdom	NW3 2QG
4	St. James's Hospital	Leeds	England	United Kingdom	LS9 7TF
5	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
6	Royal Free Hospital School of Medicine	London	England	United Kingdom	NW3 2PF
7	Guy's, King's and St. Thomas' Hospitals Trust	London	England	United Kingdom	SE1 7EH
8	Royal Marsden NHS Trust	London	England	United Kingdom	SW3 6JJ
9	Hammersmith Hospital	London	England	United Kingdom	W12 ONN
10	Middlesex Hospital- Meyerstein Institute	London	England	United Kingdom	W1N 8AA
11	Charing Cross Hospital	London	England	United Kingdom	W6 8RF
12	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England	United Kingdom	L63 4JY
13	Newcastle General Hospital	Newcastle Upon Tyne	England	United Kingdom	NE4 6BE
14	Mount Vernon Hospital	Northwood	England	United Kingdom	HA6 2RN
15	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
16	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 7LJ
17	Royal South Hants Hospital	Southampton	England	United Kingdom	SO14 0YG
18	Royal Marsden Hospital	Sutton	England	United Kingdom	SM2 5PT
19	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
20	Western General Hospital	Edinburgh	Scotland	United Kingdom	EH4 9NQ
21	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT
22	Royal Infirmary	Glasgow	Scotland	United Kingdom	G4 0SF