EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Head and Neck Neoplasms; Central Nervous System Neoplasms

Treatments: Drug: EPO906 (epothilone B)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00328458

2003-33 (Other Identifier)

JT 1035 (Other Identifier)

03C.275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Cohort 1 Brain Tumors

Experimental group

Description:

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.

Treatment:

Drug: EPO906 (epothilone B)

Cohort 2 Head and Neck Tumors

Experimental group

Description:

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.

Treatment:

Drug: EPO906 (epothilone B)