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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081614
• Other study ID #: AVF2938g
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2004
• Last updated: May 14, 2014
• Start date: March 2004
• Est. completion date: July 2005

Study information

• Verified date: May 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00091221

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastases
• Renal Cell Carcinoma

Intervention

Drug:
• Avastin (bevacizumab)

• Tarceva (erlotinib HCl)

Locations

Country	Name	City	State
United States	UCHSC - Urologic Oncology	Aurora	Colorado
United States	Lynn Regional Cancer Center - West	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Our Lady of Mercy Medical Center	Bronx	New York
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Bay Area Cancer Research Group	Concord	California
United States	Wayne State University / Harper University Hospital	Detroit	Michigan
United States	The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Northwestern Carolina Oncology & Hematology	Hickory	North Carolina
United States	UCLA School of Medicine	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Ochsner Cancer Institute	New Orleans	Louisiana
United States	NYU School of Medicine	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Raleigh Hematology Oncology	Raleigh	North Carolina
United States	Kaiser Permanente Medical Group	San Diego	California
United States	St. Joseph Oncology	St. Joseph	Missouri
United States	Bennett Cancer Center	Stamford	Connecticut
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 metastati — View Citation