EPO906 Therapy in Patients With Advanced Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Neoplasms
• Interventions: Drug: epothilone b

• Registration Number: NCT00035243
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Primary Completion: 2003-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO906	epothilone b	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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	For biomarker development

Trial Locations

Locations (8)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Centre L. Berard; 🇫🇷 Lyon, France

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Wayne State University Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

Our Lady Of Mercy Medical Center; 🇺🇸 Bronx, New York, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Institut Gustave Roussy; 🇫🇷 Villejuif, France

University of Washington; 🇺🇸 Seattle, Washington, United States