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

Fudan University

Status and phase: Suspended; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Capecitabine and Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00568529

XELOX-AGC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Combine Chemotherapy

Experimental group

Description:

XELOX(Xeloda and oxaliplatin combination)

Treatment:

Drug: Capecitabine and Oxaliplatin