EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328458
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : March 14, 2011
Novartis Pharmaceuticals
Information provided by:
Thomas Jefferson University

Brief Summary:
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 or disease Intervention/treatment Phase
Central Nervous System Neoplasms Head and Neck Neoplasms Drug: EPO906 (epothilone B) Phase 1

Thomas Jefferson University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer
Study Start Date : February 2004
Primary Completion Date : May 2008
Study Completion Date : July 2009

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the safety and toxicity profile of EPO906 when administered on a weekly schedule (maximum 7 weeks) concurrently with radiotherapy

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328458

United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Novartis Pharmaceuticals
Principal Investigator: Adam Dicker, MD, PhD Thomas Jefferson University

Additional Information:
Responsible Party: Adam Dicker, MD, Thomas Jefferson University Identifier: NCT00328458     History of Changes
Other Study ID Numbers: 03C.275
2003-33 ( Other Identifier: CCRRC )
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents