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Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

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. Identifier: NCT00259402
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : December 7, 2009
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Brief Summary:
  • 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 or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Study Start Date : February 2000
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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.

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

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.

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 identifier (NCT number): NCT00259402

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

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00259402    
Other Study ID Numbers: EFC_7127
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs