Status:
COMPLETED
A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Renal Cell Carcinoma
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00081614
Start Date
March 1 2004
End Date
July 1 2005
Last Update
May 16 2014
Active Locations (20)
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1
Bay Area Cancer Research Group
Concord, California, United States, 94520
2
UCLA School of Medicine
Los Angeles, California, United States, 90095
3
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
4
Stanford University Medical Center
Stanford, California, United States, 94305