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

NCT ID: NCT00321646

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2012-12-31

Brief 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.

Detailed Description

• Patients who are eligible for this study will undergo an endorectal MRI scan test before beginning the research study.
• After the MRI, the patient will begin the docetaxel plus bevacizumab part of the study. Each treatment cycle starts on the day you receive both drugs and lasts 21 days. Patients will undergo a total of 6 cycles-5 with docetaxel plus bevacizumab and one with docetaxel alone.
• At the beginning of each cycle, the patient will come into the clinic for a visit that will last about 3 hours. The following will happen at these visits: physical examination including vital signs and rectal exam; questions about the patients health and the medications they are taking; blood tests (both routine and research blood tests); urine tests; bevacizumab infusion; docetaxel infusion.
• The patients first dose of bevacizumab will be given on Day 1 of the first cycle over 90 minutes. If the patient tolerates the 90-minute infusion well, later doses may be given over a shorter period of time.
• The day before and the morning of the beginning of each cycle, the patient will be given a steroid called dexamethasone in pill form to help decrease the side effects of the treatment.
• The above tests and procedures will be repeated every 21 days a total of five times. For the sixth time, the patient will have all the same tests and procedures except they will not receive bevacizumab.
• After the six cycles, the patient will undergo another endorectal MRI.
• One to two months after finishing the sixth cycle, the patient will undergo a radical prostatectomy to remove their prostate.
• Two to three months after the surgery the patient will return to the clinic to have the following tests and procedures: questions about the patient's health; routine blood tests and research blood tests.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy

docetaxel and bevacizumab prior to prostatectomy

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.

Docetaxel

Intervention Type: DRUG

Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.

Interventions

Bevacizumab

Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.

Intervention Type: DRUG

Docetaxel

Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.

Intervention Type: DRUG

Other Intervention Names

Avastin; Taxotere

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Mary-Ellen Taplin, MD

OTHER

Sponsor Role: lead

Responsible Party

Mary-Ellen Taplin, MD

Assistant Professor of Medicine, HMS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mary-Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Karlou M, Tzelepi V, Efstathiou E. Therapeutic targeting of the prostate cancer microenvironment. Nat Rev Urol. 2010 Sep;7(9):494-509. doi: 10.1038/nrurol.2010.134.

Reference Type: DERIVED

PMID: 20818327 (View on PubMed)

Other Identifiers

05-438

Identifier Type: -

Identifier Source: org_study_id