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Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Not Recruiting
Trial ID: NCT00111020
Purpose
This treatment protocol allows doctors to treat advanced kidney cancer with an
investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials
for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial
in which sorafenib is compared to another equal treatment. All patients in this protocol will
be treated with sorafenib. In addition, data from the patients who participate in this
protocol will provide additional information about the drug.
Official Title
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- Patients with advanced (unresectable, recurrent or metastatic) RCC
- Patients reasonably likely to benefit from treatment with sorafenib as a single agent
therapy
- Patients with an ECOG performance status of 0-2
- Patients who will not require other systemic anticancer therapy (except for
bisphosphonates) while taking sorafenib
- Patients with vascular diseases such as wet macular degeneration, vasculitis, or new
peptic ulcer, may be enrolled but require close monitoring in accordance with
established medical practice
Exclusion Criteria:
- Patients who are currently enrolled in, are eligible for, or have access to, any other
sorafenib clinical trial
- Patients who have participated in any other sorafenib trial
- Patients who have had prior therapy with investigational agent(s) within the last four
weeks prior to study entry
- Life expectancy of less than two months
- Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
- Patients with active coronary artery disease or ischemia
- Patients with Child-Pugh class C hepatic impairment
- Patients with severe renal impairment or who require dialysis
- Patients with active uncontrolled hypertension
- Patients with recent or active bleeding diathesis
Intervention(s):
drug: Sorafenib (Nexavar, BAY43-9006)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252