EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients - Full Text View

EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

This study is currently recruiting participants.
Verified by Thomas Jefferson University, April 2007

Sponsors and Collaborators:	Thomas Jefferson University Novartis
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00328458

Purpose

The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.

Condition	Intervention	Phase
Central Nervous System Neoplasms Head and Neck Neoplasms	Drug: EPO906 (epothilone B)	Phase I

MedlinePlus related topics:

Cancer Head and Neck Cancer

ChemIDplus related topics:

Epothilone B Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase I Open-Labeled, Dose-Escalation, Safety Study of the Combination of EPO906 and Radiation Therapy (IND# 67,253) for the Treatment of Patients With Cancer

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of EPO906 when administered to the following patient cohorts who receive 3-7 weeks of radiotherapy

Secondary Outcome Measures:

To evaluate the safety and toxicity profile of EPO906 when administered on a weekly schedule (maximum 7 weeks) concurrently with radiotherapy

Estimated Enrollment:	70
Study Start Date:	February 2004
Estimated Study Completion Date:	December 2008

Detailed Description:

To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
To evaluate tumor response.

Eligibility

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

Criteria

Inclusion Criteria:

Requires a minimum of 3 weeks of radiation therapy
Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
World Health Organization (WHO) performance status equal to or less than 2
Life expectancy equal to or greater than 3 months

Exclusion Criteria:

Any peripheral neuropathy
Unresolved diarrhea greater than grade 1
Patients who received any other investigational compound within the past 28 days
Severe cardiac insufficiency
Patients on Coumadin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328458

Contacts


Contact: Adam Dicker, MD, PhD	215-955-6527	adam.dicker@mail.tju.edu

Contact: Gayle Mallon, CCRP	215-955-8619	gayle.mallon@mail.tju.edu

Locations


United States, Pennsylvania
	Thomas Jefferson University Hospital	Recruiting
	Philadelphia, Pennsylvania, United States, 19107
	Contact: Adam Dicker, MD, PhD 215-955-6527 adam.dicker@mail.tju.edu
	Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu
	Principal Investigator: Adam Dicker, MD, PhD

Sponsors and Collaborators

Thomas Jefferson University

Novartis

Investigators


Principal Investigator:	Adam Dicker, MD, PhD	Thomas Jefferson University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	03C.275
First Received:	May 19, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00328458
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

CNS and head and neck cancers

Histologically confirmed CNS malignancy head and neck

there is on standard therapy or

have failed standard therapy

Study placed in the following topic categories:

Epothilone B

Epothilones

Head and Neck Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Nervous System Diseases

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008