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Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259402
First Posted: November 29, 2005
Last Update Posted: December 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
  • To determine the activity and efficacy of the schema specified as dose regimen
  • To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

Condition Intervention Phase
Esophageal Neoplasms Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy endpoints include tumor response, progression free and overall survival. [ Time Frame: Throughout the whole study ]

Secondary Outcome Measures:
  • Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations. [ Time Frame: Throughout the whole study duration ]

Enrollment: 41
Study Start Date: February 2000
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG 0-1
  • Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
  • No previous treatment with chemotherapy or radiotherapy
  • Measurable lesion (uni or bidimensional)

Exclusion Criteria:

  • Creatinin clearance <50 mL/min
  • Total bilirubin >1.5*ULN (Upper Limit of Normal)
  • AST/ALT > 2.5*ULN
  • Total White Blood Cell <1.500.000/mL
  • Platelet count <100.000.000/mL
  • symptomatic sensitive peripheral neuropathy
  • pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259402


Locations
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: José Mª Taboada Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00259402     History of Changes
Other Study ID Numbers: EFC_7127
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Cisplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs