ABOUT THIS STUDY
1. Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy. The determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient.
2. Measurable disease is defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >/= 20 mm with conventional techniques or >/= 10 mm with spiral CT scan. This does not include primary tumors, which will be removed.
3. ECOG performance status = 1.
4. Patients must have adequate organ and marrow function within 14 days as defined below: a) absolute neutrophil count >/= 1,500/microL b) platelets >/= 75,000/microL c) Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain this level) d) total bilirubin = 2.0 mg/dl • serum creatinine = 1.5 times the upper limit of normal (ULN) e) AST(SGOT) and/or ALT (SGPT) = 2.5 X institutional ULN for subjects without evidence of liver metastases f) AST(SGOT) and/or ALT (SGPT) = 5 X institutional ULN for subjects with documented liver metastases
5. Female patients of childbearing potential (i.e. premenopausal, no hysterectomy) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study due to the possible teratogenic effect. Patients with an elevated betaHCG will undergo appropriate evaluation to rule out pregnancy (i.e. referral to Gyn service, pelvic ultrasound) and if pregnancy is ruled out and elevated betaHCG is determined to be of tumor origin, patients will be permitted to proceed on study.
6. Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study, i.e. condoms.
7. Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol.
1. Patients must not have organ allografts.
2. Patients must not have had major surgical procedure, open biopsy, or significant
traumatic injury within 14 days prior to Day 0, or anticipation of need for major
surgical procedure during the course of the study (other than defined by protocol); or
fine needle aspirations or core biopsies within 7 days prior to Day 0.
3. No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma
of any site, or other cancers for which the patient has been adequately treated and
disease free for 2 years.
4. Patients must not have received any prior anticancer therapy for renal cell carcinoma.
Radiation therapy is allowed if > 2 weeks from study drug administration.
5. Patients must not be scheduled to receive another experimental drug while on this
study. Patients are permitted to be on concomitant bisphosphonates and megestrol
6. Patients must not have a primary brain tumor (excluding meningiomas other benign
lesions), any brain metastases, leptomeningeal disease, seizure disorders not
controlled with standard medical therapy, history of stroke within the past year.
7. History of serious systemic disease, including myocardial infarction or unstable
angina within the last 12 months, history of hypertensive crisis or hypertensive
encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the
time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive
heart failure, unstable symptomatic arrhythmia requiring medication (subjects with
chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular
tachycardia are eligible), significant vascular disease or symptomatic peripheral
8. Patients must not have history of other diseases, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that
might affect the interpretation of the results of the study or render the subject at
high risk from treatment complications.
9. Patients receiving any concomitant systemic therapy for renal cell cancer are
excluded, but patients taking bisphosphonates and megestrol acetate are not excluded.
10. Patients must not require total parenteral nutrition with lipids.
11. Patients must not have clinical history of coagulopathy, bleeding diathesis or
thrombosis within the past year.
12. Patients must not have serious, non-healing wound, ulcer, or bone fracture.
13. Pregnancy (positive pregnancy test) or lactation.
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 6 months prior to study enrollment.
15. Know hypersensitivity to any component of sunitinib.
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