EPO906 Therapy in Patients With Advanced Kidney Cancer

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035243

Collaborator

(none)

Enrollment

Locations

Arm

6.6

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Neoplasms	Drug: epothilone b	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Aug 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPO906	Drug: epothilone b 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.

Arm

Intervention/Treatment

Experimental: EPO906

Drug: epothilone b

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	University of Maryland	Baltimore	Maryland	United States	21201
3	Wayne State University Karmanos Cancer Center	Detroit	Michigan	United States	48201
4	Our Lady Of Mercy Medical Center	Bronx	New York	United States	10466
5	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
6	University of Washington	Seattle	Washington	United States	98109
7	Centre L. Berard	Lyon		France
8	Institut Gustave Roussy	Villejuif		France