Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mary-Ellen Taplin, MD
• Collaborators: Beth Israel Deaconess Medical Center; Duke University; Genentech, Inc.; Sanofi
• Treatments: Bevacizumab; Docetaxel

Criteria

Inclusion Criteria:

• Histological documentation of adenocarcinoma of the prostate, with available biopsy pathology. Material from this biopsy must be available for central review at DF/HCC by the beginning of the second cycle of therapy.

• Potential candidate for radical prostatectomy

• Must meet one or more of the below characteristics: Gleason score of 8, 9 or 10; serum PSA of greater than or equal to 20 ng/mL; clinical T stage of T3; PSA velocity of greater than or equal to 2ng/mL/year in the year prior to diagnosis; Gleason score of 7 and erMRI T3 disease; Greater than or equal to 50% of the total number of biopsy cores positive for prostate cancer and either PSA > 10ng/mL or Gleason score of 7 or clinical T stage of T2a, T2b or T2c.

• Greater than six weeks since any major surgery

• Serum testosterone > 100ng/dL

• ECOG Performance Status of 0 or 1

• ANC > 1,500/ul

• Platelets > 100,000/ul

• Total bilirubin, alkaline phosphatase, AST and ALT within normal limits

• Creatinine < 2.0 x upper limit of normal

Exclusion Criteria:

• History of prior radiation, surgery or hormonal therapy treatment for prostate cancer

• Clinical evidence of metastatic prostate cancer

• Ongoing oral steroid use

• Pre-existing neuropathy of grade 2 or greater

• Severe claustrophobia, inability to lie still in a magnet for 60 minutes, a pacemaker, or any other condition that would preclude proximity to a strong magnet.

• History of the following conditions: unstable angina; symptomatic, clinically significant peripheral vascular disease; NY Heart Association Grade 2 or greater heart failure; uncontrolled hypertension; myocardial infarction or stroke < 12 months prior to enrollment; uncontrolled hypertension; active, uncontrolled infection; history of DVT, PE or known coagulopathy or bleeding diathesis; ongoing us of anticoagulant therapy; history of abdominal fistulas, GI perforation, or intra-abdominal abscess within 6 months prior to study entry; non-healing ulcer or fracture; history of another malignancy diagnosed within the last five years; spot urine protein: creatinine ratio > 1.0 at screening.