Clinical trial NCT00081614: A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Metastases
Keywords: Metastatic renal cell carcinoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: UCHSC - Urologic Oncology
state: Colorado
city: Stamford
country: United States
facility: Bennett Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Regional Cancer Center - West
state: Florida
city: New Orleans
country: United States
facility: Ochsner Cancer Institute
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University / Harper University Hospital
state: Michigan
city: St. Joseph
country: United States
facility: St. Joseph Oncology
state: Missouri
city: Hackensack
country: United States
facility: The Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Oncology & Hematology
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
citation: Bukowski RM, Kabbinavar FF, Figlin RA, Flaherty K, Srinivas S, Vaishampayan U, Drabkin HA, Dutcher J, Ryba S, Xia Q, Scappaticci FA, McDermott D. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol. 2007 Oct 10;25(29):4536-41. doi: 10.1200/JCO.2007.11.5154. Epub 2007 Sep 17.