Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Adenocarcinoma of the Prostate	Drug: Bevacizumab Drug: Docetaxel	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Bevacizumab

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the efficacy of bevacizumab plus docetaxel in the neoadjuvant treatment of men with localized, high-rish prostate cancer. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of bevacizumab plus docetaxel in the neoadjuvant treatment of men with localized, high-risk prostate cancer. [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2013
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: chemotherapy docetaxel and bevacizumab prior to prostatectomy	Drug: 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. Other Name: Avastin Drug: Docetaxel Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter. Other Name: Taxotere

Arms

Assigned Interventions

Experimental: chemotherapy

docetaxel and bevacizumab prior to prostatectomy

Drug: 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.

Other Name: Avastin

Drug: Docetaxel

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

Other Name: Taxotere

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321646

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Mary-Ellen Taplin, MD

Beth Israel Deaconess Medical Center

Duke University

Genentech

Sanofi

Investigators

Principal Investigator:

Mary-Ellen Taplin, MD

Dana-Farber Cancer Institute

More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Responsible Party:	Mary-Ellen Taplin, MD, Assistant Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00321646 History of Changes
Other Study ID Numbers:	05-438
Study First Received:	May 2, 2006
Last Updated:	February 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

prostate cancer
bevacizumab
docetaxel
radical prostatectomy

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male

Prostatic Diseases
Docetaxel
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013