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

This study has suspended participant recruitment.
(There are not enough patients enrolled.)
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00568529
First received: December 5, 2007
Last updated: May 25, 2010
Last verified: August 2009
History of Changes
  Purpose

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 Intervention Phase
Gastric Cancer
 Drug: Capecitabine and Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to progression and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: February 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568529

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

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00568529     History of Changes
Other Study ID Numbers: XELOX-AGC
Study First Received: December 5, 2007
Last Updated: May 25, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Advanced gastric cancer
Response rate
Side effects
time to progression
overall survival

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Capecitabine
 Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013