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

This study has been completed.
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00675194
First received: May 6, 2008
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Johannes Gutenberg University Mainz:
cisplatin
capecitabine
gastric
 irinotecan
metastatic
chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013