Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer
- Age > 18 years old
- Zubrod Performance Status 0 or 1
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) > 1,500/mm3
- Platelet count > 100,000/mm3
- Total bilirubin < 1.5 times institutional upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times
the institutional ULN
- Creatinine < 1.5 times institutional ULN
- Histologically or cytologically confirmed renal cell carcinoma, which is metastatic,
unresectable or recurrent.
- Life expectancy > 6 months
- Local recurrence or progression of primary lesion or progression, or symptomatic
progression in extra-cranial, extra-pulmonary metastases while on sorafenib
- Measurable disease
- Bone metastases must have a tissue component measurable by imaging.
- No untreated brain metastases
- Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste
- Willingness and ability to comply with continuing sorafenib, visits, treatment plans,
laboratory tests and study procedures.
- All treated lesions must comply with SBRT dose constraints
- More than 28 days since any prior systemic or local therapy for this cancer,
including investigational agents and surgical procedures exclusive of sorafenib
- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control)
- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment.
- Ability to understand and the willingness to sign a written informed consent.
- Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.
- Lesion in remaining (solo) kidney
- Contraindications to radiotherapy or prior radiotherapy overlapping current site(s)
- Cardiac disease: Congestive heart failure. Patients must not have unstable angina
(anginal symptoms at rest) or new onset angina (began within the last 3 months) or
myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection
- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding problems
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.