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EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

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ClinicalTrials.gov Identifier: NCT00328458
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Cohort 1 Brain Tumors
The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.
Drug: EPO906 (epothilone B)
Experimental: Cohort 2 Head and Neck Tumors
The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.
Drug: EPO906 (epothilone B)



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of EPO906 [ Time Frame: Baseline to 7 weeks ]

Secondary Outcome Measures :
  1. Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy [ Time Frame: Baseline to 7 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00328458


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Adam Dicker, MD, PhD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov 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: July 17, 2018
Last Verified: July 2018

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at 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:
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Head and Neck Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Nervous System Diseases
Neoplasms
Neoplasms by Site
Epothilones
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents