EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)

Overall Status

Completed

CT.gov ID

NCT00328458

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2004

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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)

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

Drug: EPO906 (epothilone B)

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) of EPO906 [Baseline to 7 weeks]

Secondary Outcome Measures

Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy [Baseline to 7 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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