Status:
TERMINATED
Research Study for Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00110344
Start Date
November 1 2005
End Date
June 1 2006
Last Update
October 11 2013
Active Locations (1)
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1
Boston, Massachusetts, United States, 02115-6084