Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

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

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Erlotinib + Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib + Bevacizumab<br>Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses | Drug: Erlotinib + Bevacizumab<br>* Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |