EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Study Overview
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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.

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.

Official Title
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A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer

Conditions
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Central Nervous System Neoplasms, Head and Neck Neoplasms

Intervention / Treatment
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* Drug: EPO906 (epothilone B)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 Brain Tumors<br>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)<br> <br> |
| Experimental: Cohort 2 Head and Neck Tumors<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) of EPO906 |  | Baseline to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy |  | Baseline to 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNS and head and neck cancers, Histologically confirmed CNS malignancy head and neck, there is on standard therapy or, have failed standard therapy