EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University39 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Central Nervous System Neoplasms Head and Neck Neoplasms

Interventions

EPO906 (epothilone B)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD) of EPO906

Time frame: Baseline to 7 weeks

Secondary Outcomes

Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy

Time frame: Baseline to 7 weeks

Data from ClinicalTrials.gov

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