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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nabil F. Saba, Emory University
ClinicalTrials.gov Identifier:
NCT00208936
First received: September 13, 2005
Last updated: September 5, 2014
Last verified: September 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 20
Study Start Date: January 1996
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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
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: 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

No publications provided

Responsible Party: Nabil F. Saba, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00208936     History of Changes
Other Study ID Numbers: 0691-1995
Study First Received: September 13, 2005
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Esophageal Diseases

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

ClinicalTrials.gov processed this record on October 23, 2014