Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	70 and under		EORTC-40851

Objectives

I.  Evaluate the toxicity of FAMTX (5-fluorouracil/adriamycin/methotrexate) in 
the treatment of metastatic gastric cancer.
II.  In the event that this trial is extended to a Phase III trial, determine 
objective response rate, duration of response, survival, and toxicities 
associated with FAMTX vs. FAM (5-fluorouracil/adriamycin/mitomycin-C); study 
extended to a Phase III trial in March 1987.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 70 years of age or younger 
with histologically proven gastric cancer (via primary tumor or metastatic 
biopsy).  Disease can be measurable or non-measurable, with measurable disease 
defined as:  nodular pulmonary metastases not seen on previous chest x-rays; 
palpable lymph nodes and subcutaneous masses (preferably biopsy-proven); 
hepatomegaly of more than 5 cm below the costal margin proven to contain 
metastasis (scan, laparoscopy, laparotomy, biopsy); abdominal masses with 
clear limits in the two largest perpendicular diameters; metastases with the 
largest diameter of 3 cm documented by CT or scintigraphy and echography; 
primary tumor with two clear diameters via endoscopy.  No previous 
chemotherapy or radiotherapy is allowed.  A Karnofsky performance status of 70 
or more (Zubrod 0-2), creatinine of WHO grade 0, bilirubin of 40 micromol/l or 
less, and creatinine clearance greater than 70 ml/min (in patients 60 years of 
age or older) are required.  WBC of 4 x 10 to the ninth/l or more and/or 
platelets of 100 x 10 to the ninth/l or more are required.  Active infection, 
post-surgical complication, concomitant malignant disease, CNS disease, or 
psychosis excludes.  Patients with overt cardiac disease (cardiac 
insufficiency not adequately treated, infarction within 3 months, or ejection 
fraction less than 50%) are not eligible.

Expected Enrollment

22 patients will be treated on each arm.  If the study continues to a Phase 
III trial, 198 patients will be accrued over 4 years (99 patients/arm); study 
extended to a Phase III trial in March 1987.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy plus Leucovorin Rescue.  FAMTX:  
5-Fluorouracil, 5-FU, NSC-19893; Adriamycin, ADR, NSC-123127; Methotrexate, 
MTX, NSC-740; plus Citrovorum Factor, CF, NSC-3590.
Arm II:  3-Drug Combination Chemotherapy.  FAM:  5-FU; ADR; Mitomycin-C, MITO, 
NSC-26980.

Wils J, Klein H, Bleiberg H, et al.: EORTC 40851: a Gastrointestinal (GI) Group randomized evaluation of the toxicity of sequential high dose methotrexate (MTX) and 5-Fluorouracil (F) combined with adriamycin (A) (FAMTX) versus F, A and mitomycin C (M) (FAM) in advanced gastric cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-285, 73, 1987.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jacques Wils, MD, Protocol chair(Contact information may not be current)		Ph: 31-475-334-526