EPO906 Therapy in Patients With Advanced Kidney Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Kidney Neoplasms

Treatments: Drug: epothilone b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035243

CEPO906A2207

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

EPO906

Experimental group

Treatment:

Drug: epothilone b