Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus

This study has been terminated.

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00208936

Purpose

This study is designed pre-operative for patients with resectable, local-regional carcinoma of the esophagus.

Condition	Intervention	Phase
Esophageal Diseases	Drug: Taxol, Cisplatin, 5-Fluorouracil, G-CSF	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Paclitaxel Granulocyte colony-stimulating factor Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Pre-Operative Chemotherapy With Taxol, Cisplatin, and 5-Fluorouracil Followed by G-CSF in Patients With Resectable Local-Regional Carcinoma of Esophagus

Further study details as provided by Emory University:

Estimated Enrollment:	20
Study Start Date:	January 1996

Detailed Description:

This study is designed for patients with resectable, local-regional carcinoma of the esophagus. In a pre-operative setting, chemotherapy with Taxol, Cisplatin, and 5-Fluorouracil will be administered followed by G-CSF.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Measurable disease with resectable local-regional carcinoma of the esophagus. 18 years of age or older.

Exclusion Criteria:

Pregnant or lactating. Non-resectable local-regional carcinoma of the esophagus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208936

Locations

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Michael Fanucchi, MD

Emory University Winship Cancer Institute

More Information

Study ID Numbers:	0691-1995
Study First Received:	September 13, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00208936
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Esophageal Diseases

Study placed in the following topic categories:

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

Paclitaxel
Head and Neck Neoplasms
Fluorouracil
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 16, 2009