Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib
- Registration Number
- NCT00203424
- Lead Sponsor
- Translational Oncology Research International
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erlotinib + Bevacizumab Erlotinib + Bevacizumab Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
- Primary Outcome Measures
Name Time Method 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
Name Time Method Time to Tumor Progression. Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence
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
Trial Locations
- Locations (16)
Cancer Care Associates Medical Group, Inc.
🇺🇸Redondo Beach, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Cancer Institute of Florida, P.A.
🇺🇸Orlando, Florida, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸Pomona, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
🇺🇸Santa Barbara, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
Sansum Santa Barbara Medical Foundation Clinic
🇺🇸Santa Barbara, California, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
South Texas Oncology and Hematology, P.A.
🇺🇸San Antonio, Texas, United States
Central Hematology Oncology Medical Group, Inc.
🇺🇸Alhambra, California, United States
North Valley Hematology/Oncology Medical Group
🇺🇸Northridge, California, United States
San Diego Cancer Center
🇺🇸Vista, California, United States