Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Erlotinib + Bevacizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Evaluate the Efficacy of Bevacizumab Plus Erlotinib	Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.
Time to Tumor Recurrence	Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Tumor Progression.	Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence	Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment
Overall Survival		Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment

Collaborators and Investigators

• Sponsor: Translational Oncology Research International
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 20, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Bevacizumab
• Other Study ID Numbers: TORI GU-01; 05-07-102 (OTHER: UCLA IRB)