Trial Condition(s):

Carcinoma, Renal Cell

Research Study for Patients with Metastatic Renal Cell Carcinoma

Bayer Identifier:

11547

ClinicalTrials.gov Identifier:

NCT00110344

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

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

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

Trial Summary

Enrollment Goal
1
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dana-Farber Cancer Institute

Boston, United States, 02115-6084

Status
Completed
 

Trial Design