A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer
Inclusion Criteria:
- Signed Informed Consent Form
- Histologically confirmed metastatic RCC
- Measurable disease, as defined by RECIST
- Age ≥ 18 years
- ECOG performance status of 0 or 1
- Prior nephrectomy
- Ability and capacity to comply with study and follow-up procedures
Exclusion Criteria:
- RCC with predominantly sarcomatoid features
- Prior systemic or adjuvant therapy for RCC
- Radiotherapy for RCC within 28 days prior to Day 1
- Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or
other similar agents
- Current need for dialysis
- Life expectancy of < 12 weeks
- Current, recent, or planned participation in an experimental drug study
- Inadequate organ function
- Active infection or fever > 38.5°C within 3 days of starting treatment
- History of other malignancies within 5 years prior to Day 1
- Any other medical conditions (including mental illness or substance abuse) deemed by
the clinician to be likely to interfere with a patient's ability to provide informed
consent, cooperate, or participate in the study, or to interfere with the
interpretation of the results
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Class II or greater CHF
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known CNS disease except for treated brain metastasis
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within 6 months prior to Day 1
- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month
prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)
- Major surgical procedure or anticipation of need for major surgical procedure during
the course of the study
- Serious, non-healing wound; active ulcer; or untreated bone fracture
- Known hypersensitivity to any component of bevacizumab
- Pregnancy (positive pregnancy test) or lactation
- Current, ongoing treatment with full-dose warfarin