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NCT00328458 Clinical Trial

EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00328458
Other study ID # 03C.275
Secondary ID 2003-33
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2004
Est. completion date July 2009

Study information
Verified date July 2018
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date July 2009
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• EPO906 (epothilone B)

Locations
Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of EPO906 Baseline to 7 weeks
Secondary Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy Baseline to 7 weeks
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