Title Phase I/II Study of Dalteparin, A Low Molecular Weight Heparin (LMWH), in Combination with Sunitinub (SU11248), an Oral, Selective Multitareted Tyrosine Kinase Inhibitor, as First Line Treatment, in Patients with Metastatic Renal Cell Carcinoma
Principal Investigator Roberto Pili, MD
Study Number 145508
This research study is being done to see if the addition of Dalteparin to the standard treatment (Sunitinib) slows tumor growth in vascular tumors like renal cell carcinoma by stopping vessel growth. Dalteparin is an anticoagulant used against blood clots but has also been shown to stop blood vessel growth. Dalteparin has been shown to increase the survival of patients with cancer. Sunitinib blocks the activation of multiple growth factor receptors involved in vessel and tumor growth. Sunitinib is the common name for the commercial drug Sutent. Sunitinib is the standard of care for patients with advanced kidney cancer, but is not curative. Dalteparin and Sunitinib are approved by the Food and Drug Administration (FDA) and are commercially available. However, the combination of these drugs Dalteparin and Sunitinib has not been tested in humans. Thus, the effects of these drugs in combination, good and bad, and the correct dose of the drugs to give are unknown.
- Patients must have histologically confirmed metastatic or unresectable renal cell carcinoma
- Clear cell and non-clear renal carcinoma patients are eligible. Oncocytoma, collecting duct tumors, and transitional cell carcinoma are NOT eligible
- No prior systemic treatments for metastatic disease are permitted, including antiangiogenic therapy, immunotherapy, chemotherapy and investigational therapy
- Patients with their primary tumor in place who are appropriate surgical candidates should be strongly encouraged to undergo nephrectomy prior to treatment initiation, based on the potential effect on survival
- Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been radiated.