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

Phase 2
18 Years
70 Years
Not Enrolling
Gastric Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Outcome Time Frame:

2-6 months

Safety Issue:


Principal Investigator

Jin Li, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

October 2007

Completion Date:

February 2010

Related Keywords:

  • Gastric Cancer
  • Advanced gastric cancer
  • Response rate
  • Side effects
  • time to progression
  • overall survival
  • Stomach Neoplasms