EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Central Nervous System Neoplasms Head and Neck Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EPO906 (epothilone B)

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

EPO906 (epothilone B)

Intervention Type DRUG

Interventions

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EPO906 (epothilone B)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No