Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Epirubicin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach

• ECOG performance scale ≤2

• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

• Adequate hepatic, renal, heart, and hematologic functions (platelets >80×109/L, neutrophil>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

• Pregnant or lactating women

• Concurrent cancer

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

• Neuropathy, brain, or leptomeningeal involvement

• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia

• Uncontrolled significant comorbid conditions and previous radiotherapy