Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00259402
First received: November 28, 2005
Last updated: December 4, 2009
Last verified: December 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00259402

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00259402     History of Changes
Other Study ID Numbers: EFC_7127
Study First Received: November 28, 2005
Last Updated: December 4, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on August 01, 2014