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A Phase III Study of Axitinib versus Sorafenib as Second-line Therapy for Metastatic Renal Cell Cancer: the AXIS trial
[Protocol 08-059]
- Full Title :
- AXITINIB(AG-013736)AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
- Purpose :
Sorafenib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of kidney cancer. Axitinib, an investigational drug not yet approved by the FDA, is thought to work by preventing the growth of new blood vessels that tumors need to grow and spread, by targeting a protein called the vascular endothelial growth factor.
The purpose of this study is to determine whether axitinib can keep previously treated metastatic renal cell cancer from growing for a longer period of time compared to sorafenib; to see whether patients taking axitinib live longer than patients taking sorafenib; and to compare the effects of the drugs on the body and on patients' quality of life. Patients will receive either sorafenib or axitinib, but not both. Both drugs are taken orally (by mouth).
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of metastatic renal cell carcinoma that has persisted or returned despite one prior regimen of chemotherapy that included one or more of the following: sunitinib, bevacizumab with interferon-alpha, temsirolimus, or
cytokine therapy.
- At least 2 weeks must have passed since completion of prior therapies and entry into the study (4 weeks since bevacizumab/interferon or major surgery).
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older
For more information and to inquire about eligibility for this study, please contact Dr. Robert Motzer at 646-422-4312.
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