A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma
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
1 other identifier
interventional
100
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2004
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 15, 2004
CompletedFirst Posted
Study publicly available on registry
April 20, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedMay 16, 2014
May 1, 2014
April 15, 2004
May 14, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (20)
Bay Area Cancer Research Group
Concord, California, 94520, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Kaiser Permanente Medical Group
San Diego, California, 92120, United States
Stanford University Medical Center
Stanford, California, 94305, United States
UCHSC - Urologic Oncology
Aurora, Colorado, 80010, United States
Bennett Cancer Center
Stamford, Connecticut, 06902, United States
Lynn Regional Cancer Center - West
Boca Raton, Florida, 33428, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University / Harper University Hospital
Detroit, Michigan, 48201, United States
St. Joseph Oncology
Saint Joseph, Missouri, 64507, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
NYU School of Medicine
New York, New York, 10016, United States
Our Lady of Mercy Medical Center
The Bronx, New York, 10466, United States
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, 28601, United States
Raleigh Hematology Oncology
Raleigh, North Carolina, 27609, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19004, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Related Publications (2)
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.
PMID: 17876014RESULTAldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PMID: 37146227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2004
First Posted
April 20, 2004
Study Start
March 1, 2004
Study Completion
July 1, 2005
Last Updated
May 16, 2014
Record last verified: 2014-05