A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma

Inclusion Criteria:

Written informed consent
Histologically confirmed RCC of clear cell histology
Confirmed metastatic RCC
Age >=18 years
ECOG performance status of 0 or 1
Life expectancy >=3 months
Prior nephrectomy
Measurable disease, as defined by RECIST
Use of an acceptable means of contraception (potentially fertile men and women)

Exclusion Criteria:

RCC with predominantly sarcomatoid features
Prior systemic or adjuvant therapy for RCC
Prior radiotherapy for RCC within 28 days prior to Day 0, with the exception of single fraction radiotherapy given for the indication of pain control
Treatment with Avastin, Tarceva, or other agents, either investigational or marketed, that act by either EGFR inhibition or anti-angiogenesis mechanisms
24-hour urine collection with >=1 g of protein
INR >=1.5, except for subjects receiving warfarin therapy
Serum creatinine >2.0 mg/dL
Serum calcium >10 mg/dL (corrected)
Absolute neutrophil count (ANC) <1500/uL
Platelet count <75,000/uL
Total bilirubin >2.0 mg/dL
AST or ALT >5× the upper limit of normal (ULN) for subjects with documented liver metastases; >2.5 × ULN for subjects without evidence of liver metastases
LDH >1.5× ULN
Hemoglobin <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >160/110 mmHg on medication), unstable angina, 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), or Grade II or greater peripheral vascular disease
History of acute stroke within 6 months prior to randomization
Patients on dialysis
Other invasive malignancies, including bladder cancer and low-grade endometrial cancer, within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
Pregnancy or breast feeding
Inability to comply with study and/or follow-up procedures
History of other disease, 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
Serious, non-healing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy
History or clinical evidence of central nervous system or brain metastases
History of bowel or gastric perforation

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study

Fine needle aspirations or core biopsies within 7 days prior to Day 0