Study of Sorafenib and Palliative Radiotherapy in Kidney Cancer That Spreads to the Bone

Inclusion Criteria

• •Eligibility Criteria
• •1. Eligible patients must have histologically or cytologically confirmed metastatic RCC that is judged to be incurable with standard therapy.
• •2. Patients must have at least one radiographically-evident symptomatic (\> 2/10 on the Brief Pain Inventory) bone metastasis that is amenable to palliative radiation. Multiple symptomatic bone metastases may be irradiated at the same time. However, if more than one symptomatic bone metastasis is identified, one will be chosen as the index lesion for reporting purposes.
• •3. No planned change in analgesic medications.
• •4. No planned increase in regular analgesic medications.
• •5. No prior surgery to the index lesion, although previous surgery for other metastatic disease is permissible if \> 4 weeks prior to study registration.
• •6. Patients may have had up to two previous lines of systemic treatment for metastatic RCC, including prior treatment with sorafenib or another similar multi-targeted tyrosine kinase inhibitor, if completed \>4 weeks prior to study registration.
• •7. Patients may not have had previous radiotherapy to the index lesion. Patients may have had previous radiotherapy to other metastases if completed \> 4 weeks prior to study registration. Patients must have recovered from the acute side effects of radiotherapy prior to study registration.
• •8. Age \>18 years.
• •9. Life expectancy of greater than 3 months.
• •10. ECOG performance status \< 2 (Karnofsky \> 60).
• •11. Patients must have normal organ and marrow function as defined below:
• •i. Absolute neutrophil count \>1.5 x109 /L ii. Platelet count \>75 x109 /L iii. Total bilirubin \< 1.5 x ULN iv. AST (SGOT) / ALT (SGPT) \< 2.5 × institutional ULN or \< 5 x institutional ULN if liver metastases v. Creatinine \<1.7 x ULN or vi. Creatinine clearance \> 50 mL/min/1.73 m2 vii. International Normalized Ratio (INR) \< 1.5 viii. Hemoglobin value Hb \> 80 g/L ix. Serum phosphate level \> 0.80 mmol/L x. Serum lipase, normal values (range of 5-208 U/L) xi. Serum amylase, normal values (range 30-110 U/L)
• •12. Ability to understand and the willingness to sign a written informed consent document.
• •13. The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Effective methods of birth control would include a barrier method (e.g. condoms, diaphragm) combined with spermicide, or an intrauterine device (IUD). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.