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

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 II

MedlinePlus related topics:

Cancer Esophageal Cancer Esophagus Disorders

ChemIDplus related topics:

Cisplatin Fluorouracil Oxaliplatin

U.S. FDA Resources

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
Estimated Primary Completion Date:	September 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

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

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

Locations


Spain
	Sanofi-Aventis
	Barcelona, Spain

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
First Received:	November 28, 2005
Last Updated:	August 4, 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 October 06, 2008

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