EPO906 Therapy in Patients With Advanced Kidney Cancer

Study Overview
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Brief Summary
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This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

Official Title
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An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Drug: epothilone b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following patients may be eligible for this study: Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) Patients must have had a prior nephrectomy Must have a life expectancy of greater than three (3) months Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible. Exclusion Criteria: The following patients are not eligible for this study: Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible Patients who have had any prior chemotherapy (including a combination therapy) Patients with symptomatic CNS metastases or leptomeningeal involvement Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 Patients with severe cardiac insufficiency Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports History of another malignancy within 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae HIV+ patients Pregnant or lactating females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPO906<br> | Drug: epothilone b<br>* EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) |  | every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | every 8 weeks | 
| Time to disease progression (TTP) |  | every 8 weeks | 
| Overall Survival (OS) |  | every 8 weeks | 
| Safety and tolerability of EPO906 |  | at each visit | 
| Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma | For biomarker development | prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney cancer, renal cancer, cancer, tumor, tumour, neoplasm, carcinoma, clear cell, sarcomatoid, papillary, medullary, collecting duct, chromophobe, intravenous, epothilone