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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00081614
First received: April 15, 2004
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Metastases
Drug: Avastin (bevacizumab)
Drug: Tarceva (erlotinib HCl)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Genentech:

Estimated Enrollment: 100
Study Start Date: March 2004
Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081614

Locations
United States, California
Bay Area Cancer Research Group
Concord, California, United States, 94520
UCLA School of Medicine
Los Angeles, California, United States, 90095
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
UCHSC - Urologic Oncology
Aurora, Colorado, United States, 80010
United States, Connecticut
Bennett Cancer Center
Stamford, Connecticut, United States, 06902
United States, Florida
Lynn Regional Cancer Center - West
Boca Raton, Florida, United States, 33428
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University / Harper University Hospital
Detroit, Michigan, United States, 48201
United States, Missouri
St. Joseph Oncology
St. Joseph, Missouri, United States, 64507
United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU School of Medicine
New York, New York, United States, 10016
United States, North Carolina
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, United States, 28601
Raleigh Hematology Oncology
Raleigh, North Carolina, United States, 27609
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19004
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Genentech
  More Information

Publications:
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00081614     History of Changes
Obsolete Identifiers: NCT00091221
Other Study ID Numbers: AVF2938g
Study First Received: April 15, 2004
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014