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

Phase 2

Suspended

• Conditions: Gastric Cancer
• Interventions: Drug: Capecitabine and Oxaliplatin

• Registration Number: NCT00568529
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2009-06
• Status Verified: 2009-08
• Study Completion: 2010-02
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combine Chemotherapy	Capecitabine and Oxaliplatin	XELOX(Xeloda and oxaliplatin combination)

Primary Outcome Measures

Name	Time	Method
Response Rate	2-6 months

Secondary Outcome Measures

Name	Time	Method
time to progression and overall survival	1 year

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China