EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Phase 1

Completed

• Conditions: Central Nervous System Neoplasms; Head and Neck Neoplasms
• Interventions: Drug: EPO906 (epothilone B)

• Registration Number: NCT00328458
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Primary Completion: 2008-05
• Study Completion: 2009-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 Brain Tumors	EPO906 (epothilone B)	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.
Cohort 2 Head and Neck Tumors	EPO906 (epothilone B)	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of EPO906	Baseline to 7 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy	Baseline to 7 weeks

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States