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

Gastric Cancer Clinical Trial

Official title:

Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00568529
• Other study ID #: XELOX-AGC
• Status: Suspended
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: May 25, 2010
• Start date: October 2007
• Est. completion date: February 2010

Study information

• Verified date: August 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine and Oxaliplatin
Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		2-6 months	No
Secondary	time to progression and overall survival		1 year	No