Oxaliplatin in Esophagus Cancer (Advanced) 1st Line - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00259402

Purpose

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

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Fluorouracil Oxaliplatin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Open-Label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	43
Study Start Date:	February 2000
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxaliplatin: Experimental	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

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259402

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

José Mª Taboada

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	EFC_7127
Study First Received:	November 28, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00259402
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Esophageal disorder
Gastrointestinal Diseases

Fluorouracil
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009