Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

• Status: Suspended
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

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

Details

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

Criteria

Inclusion Criteria:

• Age between 18 and 70 years

• Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma

• ECOG performance status ≤1

• Measurable diseases according to the RECIST

• Relapse or refractory after the first-line chemotherapy

• Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).

Exclusion Criteria:

• Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin

• Have used any of drugs in the regimen in first-line chemotherapy

• Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection

• The evidence of CNS metastasis

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

• Received other chemotherapy regimen after metastasis

• Participated in other clinical trials.