EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00328458
First received: May 19, 2006
Last updated: March 11, 2011
Last verified: March 2011
  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 1

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Enrollment: 39
Study Start Date: February 2004
Study Completion Date: July 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
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: NCT00328458

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

Additional Information:
No publications provided

Responsible Party: Adam Dicker, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00328458     History of Changes
Other Study ID Numbers: 03C.275, 2003-33
Study First Received: May 19, 2006
Last Updated: March 11, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Neoplasms
Head and Neck Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Epothilone B
Epothilones
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014