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Active Not Recruiting
NCT00715442
Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)
Conditions: Renal Cell Carcinoma
Sex: All
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: M.D. Anderson Cancer Center
Location: Baylor College of Medicine Houston Texas
Summary
The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied.
Eligibility Criteria
Inclusion Criteria:
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 \/= 1,500/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 \
Source: ClinicalTrials.gov (NCT00715442). StuddyBuddy aggregates publicly available trial information.