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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014