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

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568529

Enrollment

Registered

2007-12-06

Start date

2007-10-31

Completion date

2010-02-28

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Advanced gastric cancer, Response rate, Side effects, time to progression, overall survival

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.

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.

Interventions

DRUGCapecitabine and Oxaliplatin

Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Response Rate	2-6 months

Secondary

Measure	Time frame
time to progression and overall survival	1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026