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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 5, 2007

Last Updated Date

December 5, 2007

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

Response Rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

TTP and OS [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX 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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Gastric Cancer

Intervention ^†

Drug: Capecitabine and Oxaliplatin

Study Arms / Comparison Groups

Experimental: XELOX

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Biyun Wang, M.D.

8613701748410

wangbiyun@msn.com

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00568529

Responsible Party

Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital

Secondary IDs ^††

Study Sponsor ^†

Fudan University

Collaborators ^††

Investigators ^†

Principal Investigator:

Jin Li, PhD

Fudan University Cancer Hospital

Information Provided By

Fudan University

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.