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

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00568529

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: Capecitabine and Oxaliplatin	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Capecitabine Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Further study details as provided by Fudan University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
A: Experimental XELOX	Drug: Capecitabine and Oxaliplatin Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

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

Contacts

Contact: Biyun Wang, M.D.

8613701748410

wangbiyun@msn.com

Locations

China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Sub-Investigator: Biyun Wang, M.D.

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Jin Li, PhD

Fudan University Cancer Hospital

More Information

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

Keywords provided by Fudan University:

Advanced gastric cancer
Response rate
TTP
OS

Side effects
time to progression
overall survival

Study placed in the following topic categories:

Oxaliplatin
Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms

Gastrointestinal Diseases
Stomach Neoplasms
Disease Progression
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009