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Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib
This study is currently recruiting participants.
Verified by Translational Oncology Research International, March 2006
Sponsors and Collaborators: Translational Oncology Research International
Genentech
Information provided by: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00203424
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.


Condition Intervention Phase
Prostate Cancer
Drug: Erlotinib
Drug: Bevacizumab
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer

Further study details as provided by Translational Oncology Research International:

Primary Outcome Measures:
  • • To evaluate the efficacy of bevacizumab plus
  • erlotinib determined by time to tumor recurrence, as
  • measured by rising PSA after radical prostatectomy.
  • Rising PSA is defined as an increase of PSA to 0.3
  • ng/dl or more in patients with a post-RP PSA that is
  • undetectable or < 0.1 ng/dl, or a rise of >50% in
  • patients where post-RP remains > 0.1 ng/dl.

Secondary Outcome Measures:
  • • To determine time to tumor progression as measured
  • radiographically by time to development of either
  • local recurrence, or metastatic bone or soft tissue
  • disease after radical prostatectomy
  • • To evaluate the safety/toxicity of this treatment
  • regimen
  • • To evaluate overall survival

Estimated Enrollment: 30
Study Start Date: June 2005
Detailed Description:

This study explores the anti-tumor activity of adjuvant bevacizumab plus erlotinib in a select group of prostate cancer patients deemed at high risk for early relapse following radical prostatectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky performance status of > 80
  • Patients must have localized, organ-confined prostate cancer documented by physical examination, CT scan, or bone scan, and must have undergone radical prostatectomy. Post RP must have documented node negative prostate cancer.
  • Pretreatment granulocyte count > 1500/mm3, hemoglobin > 9.0 g/dL, and platelet count > 100,000/mm3,
  • Normal PT and PTT
  • Serum creatinine < 2.0 mg/dL
  • Adequate hepatic function with a serum bilirubin < upper limit of normal (ULN), AST and ALT < 1.5x ULN, and alkaline phosphatase < 2.5x ULN.
  • High-risk prostate cancer defined as a pre-RP prostate specific antigen level > 15 ng/dL or a Gleason score of > 8 or Stage T3 disease or positive surgical margins
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months thereafter

Exclusion Criteria:

  • Evidence of small cell (neuroendocrine) tumor
  • Evidence of metastatic disease
  • Prior administration of immunotherapy, biological therapy, hormonal therapy or radiation therapy for prostate cancer
  • Active secondary malignancies (other than basal cell carcinoma of the skin)
  • Serious, nonhealing wound, ulcer, or bone fracture.
  • Clinically significant cardiovascular disease (e.g., blood pressure of >150/100 mmHg, myocardial infarction, or unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or clinically significant peripheral vascular disease. Patients with a history of myocardial infarction or stroke within the last 6 months will be excluded.
  • Presence of seizures not controlled with standard medical therapy
  • Active infection requiring parenteral antibiotics at the time of the first administration of study drugs
  • 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; minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study
  • Inability to comply with the study visit and follow-up schedule or 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.
  • Urine protein:creatinine ration > 1.0 at screening
  • Evidence of bleeding diathesis or coagulopathy.
  • History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days prior to Day 0.
  • Presence of central nervous system or brain metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203424

Contacts
Contact: Jim Muff (310) 824-1934 jm@tori.org
Contact: Nancy Ryba, RN (310) 794-6500 nryba@mednet.ucla.edu

Locations
United States, California
Cancer Care Associates Medical Group, Inc. Recruiting
Redondo Beach, California, United States, 90277
Contact: Sherry Hutcherson, RN     310-750-3376        
Principal Investigator: David Chan, MD            
Central Coast Medical Oncology Corporation Recruiting
Santa Maria, California, United States, 93454
Contact: Alison Fernandez, RN     805-349-9393        
Principal Investigator: Robert Dichmann, MD            
Central Hematology Oncology Medical Group, Inc. Recruiting
Alhambra, California, United States, 91801
Contact: Helene Yang     626-588-2825        
Principal Investigator: Eddie H. Hu, MD            
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Lori Glass     661-862-7158        
Principal Investigator: Ravi Patel, MD            
Sansum Santa Barbara Medical Foundation Clinic Recruiting
Santa Barbara, California, United States, 93105
Contact: Margot Jakab     805-569-7459        
Principal Investigator: Julie A. Taguchi, MD            
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
Contact: Teresa Olea, RN     562-590-0345        
Principal Investigator: Andre Kiem Dian Liem, MD            
San Diego Cancer Center Not yet recruiting
Vista, California, United States, 92081
Contact: Christine DeFrancisco, RN     760-598-1700        
Principal Investigator: Mark J. Adler, MD            
North Valley Hematology/Oncology Medical Group Recruiting
Northridge, California, United States, 91328
Contact: Pamela Riach, RN     818-885-8500 ext 2832        
Principal Investigator: Sheldon J. Davidson, MD            
Santa Barbara Hematology Oncology Medical Group, Inc. Recruiting
Santa Barbara, California, United States, 93105
Contact: Margot Jakab     805-569-7459        
Principal Investigator: Frederic C. Kass, MD            
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Nathalie Chorn, RN     310-825-4493        
Principal Investigator: Fairooz Kabbinavar, MD            
Ventura County Hematology-Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Contact: Pamela Riach, RN     805-485-8709        
Principal Investigator: Rosemary E McIntyre, MD            
Virginia K. Crosson Cancer Center Recruiting
Fullerton, California, United States, 92835
Contact: Gayle Madden-Mathes, RN     714-446-5804        
Principal Investigator: Richard E. Lloyd, MD            
Wilshire Oncology Medical Group, Inc. Recruiting
Pomona, California, United States, 91767
Contact: Viet Pham     909-596-5333        
Principal Investigator: Linda D. Bosserman, MD            
United States, Florida
Cancer Institute of Florida, P.A. Not yet recruiting
Orlando, Florida, United States, 32804
Contact: Jane Crofton, RN     407-303-2090        
Principal Investigator: Rebecca L. Moroose, MD            
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Eve Stork, RN     702-952-3400 ext 5422        
Contact: Donna Katz, RN     702-952-3444 ext 5525        
Principal Investigator: Heather J. Allen, MD            
United States, Texas
South Texas Oncology and Hematology, P.A. Recruiting
San Antonio, Texas, United States, 78207
Contact: Sandra Hendricks     210-593-2634        
Contact: Dolly Fischer     210-616-7978        
Principal Investigator: Gladys I. Rodriguez, MD            
Sponsors and Collaborators
Translational Oncology Research International
Genentech
Investigators
Study Chair: Fairooz Kabbinavar, MD Chief Medical Officer, TORI
  More Information

TORI Home Page, with contact information listed  This link exits the ClinicalTrials.gov site

Study ID Numbers: TORI GU-01
Study First Received: September 13, 2005
Last Updated: March 7, 2006
ClinicalTrials.gov Identifier: NCT00203424  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Erlotinib
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Bevacizumab
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009