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

Primary Purpose

Prostate Cancer, Adenocarcinoma of the Prostate

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Docetaxel
Sponsored by
Mary-Ellen Taplin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, bevacizumab, docetaxel, radical prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy

Arm Description

docetaxel and bevacizumab prior to prostatectomy

Outcomes

Primary Outcome Measures

Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy
A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.

Secondary Outcome Measures

PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.
The rate of PSA decline by 50% compared to baseline PSA.

Full Information

First Posted
May 2, 2006
Last Updated
April 13, 2016
Sponsor
Mary-Ellen Taplin, MD
Collaborators
Beth Israel Deaconess Medical Center, Duke University, Genentech, Inc., Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00321646
Brief Title
Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Official Title
A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mary-Ellen Taplin, MD
Collaborators
Beth Israel Deaconess Medical Center, Duke University, Genentech, Inc., Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma of the Prostate
Keywords
prostate cancer, bevacizumab, docetaxel, radical prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy
Arm Type
Experimental
Arm Description
docetaxel and bevacizumab prior to prostatectomy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Primary Outcome Measure Information:
Title
Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy
Description
A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.
Time Frame
after 6 months of neoadjuvant chemotherapy.
Secondary Outcome Measure Information:
Title
PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.
Description
The rate of PSA decline by 50% compared to baseline PSA.
Time Frame
after 6 months of ajuvant chemotherapy.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Ellen Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20818327
Citation
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.
Results Reference
derived

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

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