A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma
Data Collection
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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 the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
UCLA School of Medicine
Los Angeles, United StatesKaiser Permanente Medical Group
San Diego, United StatesStanford University Medical Center
Stanford, United States