Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Translational Oncology Research International
ClinicalTrials.gov Identifier:
NCT00203424
First received: September 13, 2005
Last updated: May 24, 2011
Last verified: May 2011
  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 + Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Translational Oncology Research International:

Primary Outcome Measures:
  • To Evaluate the Efficacy of Bevacizumab Plus Erlotinib [ Time Frame: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy. ] [ Designated as safety issue: Yes ]
  • Time to Tumor Recurrence [ Time Frame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Tumor Progression. [ Time Frame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment ] [ Designated as safety issue: No ]
    Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence

  • Overall Survival [ Time Frame: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2006
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib + Bevacizumab
Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
Drug: Erlotinib + Bevacizumab
Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

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
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: NCT00203424

Locations
United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Pacific Shores Medical Group
Long Beach, California, United States, 90813
UCLA Medical Center
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91328
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
San Diego Cancer Center
Vista, California, United States, 92081
United States, Florida
Cancer Institute of Florida, P.A.
Orlando, Florida, United States, 32804
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, Texas
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Translational Oncology Research International
Genentech
Investigators
Study Chair: Fairooz Kabbinavar, MD Chief Medical Officer, TORI
  More Information

No publications provided

Responsible Party: Fairooz Kabbinavar, Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00203424     History of Changes
Other Study ID Numbers: TORI GU-01, 05-07-102
Study First Received: September 13, 2005
Results First Received: April 12, 2011
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
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 September 30, 2014