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

NCT00321646 | Completed Phase 2 Results DMC

• 1 other identifier: 05-438
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate

Keywords

prostate cancer; bevacizumab; docetaxel; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  after 6 months of neoadjuvant chemotherapy.

Secondary Outcomes (1)

• PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.

  after 6 months of ajuvant chemotherapy.

Study Arms (1)

chemotherapy

EXPERIMENTAL

docetaxel and bevacizumab prior to prostatectomy

Drug: Bevacizumab; Drug: Docetaxel

Interventions

Bevacizumab 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.

Also known as: Avastin

chemotherapy

Docetaxel DRUG

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

Also known as: Taxotere

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mary-Ellen Taplin, MD: lead
• Beth Israel Deaconess Medical Center: collaborator
• Duke University: collaborator
• Genentech, Inc.: collaborator
• Sanofi: collaborator

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 20818327 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bevacizumab; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Mary-Ellen Taplin, MD
• Organization: Dana-Farber Cancer Institute

mary_taplin@dfci.harvard.edu

617-582-8313

Study Officials

• Mary-Ellen Taplin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine, HMS

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: June 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2012
• Last Updated: May 16, 2016
• Results First Posted: December 25, 2013

Record last verified: 2016-04

Locations

US (3)