Research Study for Patients With Metastatic Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Sorafenib

Criteria

Inclusion Criteria:

• Life expectancy of at least 12 weeks

• Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon

• At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen

• Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria:

• History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation

• Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field

• Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry