Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer - Full Text View

Sponsored by:	Johannes Gutenberg University Mainz
Information provided by:	Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:	NCT00675194

Purpose

The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer

Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety

Condition	Intervention	Phase
Gastric Cancer	Drug: Cisplatin, Irinotecan, Capecitabine	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:

response rate

Secondary Outcome Measures:

safety
progression free survival
1 year survival
Quality of Life
Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients

Estimated Enrollment:	120
Study Start Date:	October 2003
Study Completion Date:	October 2007

Detailed Description:

capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

gastric or gastric-oesophagal junction adenocarcinoma
unidimensional measurable disease
Karnofsky index >/=60%

Exclusion Criteria:

prior chemo- or radiotherapy
colorectal diseases
brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675194

Locations

Germany
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
Mainz, Germany, 55101

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

Principal Investigator:

Markus Moehler, MD

Johannes Gutenberg University Mainz

More Information

Study ID Numbers:	GC-ICE-2003
Study First Received:	May 6, 2008
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00675194
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:

cisplatin
capecitabine
gastric

irinotecan
metastatic
chemotherapy

Study placed in the following topic categories:

Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases

Stomach Neoplasms
Irinotecan
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009