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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568529
Recruitment Status : Suspended (There are not enough patients enrolled.)
First Posted : December 6, 2007
Last Update Posted : May 26, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine and Oxaliplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Combine Chemotherapy
XELOX(Xeloda and oxaliplatin combination)
Drug: Capecitabine and Oxaliplatin
Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
Other Name: XELOX(Xeloda and oxaliplatin combination)

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 2-6 months ]

Secondary Outcome Measures :
  1. time to progression and overall survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568529

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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
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Principal Investigator: Jin Li, PhD Fudan University

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Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital Identifier: NCT00568529    
Other Study ID Numbers: XELOX-AGC
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: August 2009
Keywords provided by Fudan University:
Advanced gastric cancer
Response rate
Side effects
time to progression
overall survival
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents