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A Phase I/II Trial of Pazopanib Alternating with Bevacizumab in Treatment-Naïve Metastatic Clear Cell Renal Cell Carcinoma Patients

Protocol No
RPCI-I-191711
Principal Investigator
Deepak Kilari
Phase
I/II
Summary
Metastatic kidney cancer is a disease with no cure. The FDA has recently approved the use of sunitinib, pazopanib and bevacizumab in combination with interferon for patients who have not had any treatment for this disease. Unfortunately, all the above treatments become ineffective after about 5 to 11 months of treatment. In some patients taking pazopanib, disease does not progress for approximately 9.2 months. Bevacizumab taken in combination with interferon has been effective in stopping disease progression for approximately 8.4 to 10.2 months. We believe these drugs stop being useful after a period of time because the cancer becomes resistant to them and they are no longer an effective treatment. This study will evaluate the effect of a treatment using the two drugs pazopanib and bevacizumab in an alternating fashion. The purpose of alternating (taking one drug and then the other) treatment with these two drugs is to try and prevent your cancer from developing a resistance to these drugs. Pazopanib will be taken by mouth at home and bevacizumab will be administered by intravenous infusion in the clinic. Intravenous infusion is through a tube inserted by needle in a vein in your arm. This is a combined Phase I and Phase II study. The Phase I part of this study is to determine the highest safe dose for use in Phase II. Once the highest safe dose of the 2 drug treatments is found, the Phase II study will begin. The Phase I portion has been completed, and only the Phase II part of the study will be done at this site. The Phase II dose level has been established enabling enrollment to the Phase II portion. The purpose of this study is to find out what effects (good and bad) pazopanib and bevacizumab will have in patients with your type of advanced kidney cancer. We will also perform blood studies to determine how this treatment is affecting your cancer. These studies will look to see: - how many growth factor cells (cells that help cancer progress) - how many immune related cells (cells that effect your immune system) - how much of the drug pazopanib is in your blood
Description
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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