CompletedNCT00321646Updated May 16, 2016Results posted

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

A Phase 2 interventional study of Bevacizumab and Docetaxel in Prostate Cancer and Adenocarcinoma of the Prostate, sponsored by Mary-Ellen Taplin, MD. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-16.

Sponsored by Mary-Ellen Taplin, MD · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 42
Allocation: Not applicable
Ages: 18 Years and older
Sex: Male

Study 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.

Read the 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 studied

Prostate Cancer
Adenocarcinoma of the Prostate

Browse trials for

Prostatic Neoplasms 6,370

Keywords

prostate cancer
bevacizumab
docetaxel
radical prostatectomy

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 42 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Mary-Ellen Taplin, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
chemotherapy
docetaxel and bevacizumab prior to prostatectomy
Drug: Bevacizumab · Drug: Docetaxel

Interventions

DrugBevacizumab
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
DrugDocetaxel
Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Also known as: Taxotere

What researchers measure

Primary outcomes

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.
Time frame: after 6 months of neoadjuvant chemotherapy.

Secondary outcomes

PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.
The rate of PSA decline by 50% compared to baseline PSA.
Time frame: after 6 months of ajuvant chemotherapy.

Results

Posted Dec 25, 2013

Participant flow

42 subjects were consented, screened, registered and enrolled between 7/27/06 and 3/24/09 in the relevant clinics at Duke University (5 subjects) and DF/HCC (37 subjects).

Neoadjuvant Chemotherapy

Participant flow — Neoadjuvant Chemotherapy
Milestone	Chemotherapy
Started	42
Completed	38
Not completed	4
Withdrew: Withdrawal by subject	1
Withdrew: Adverse event	2
Withdrew: Disease progression	1

Prostatectomy

Participant flow — Prostatectomy
Milestone	Chemotherapy
Started	37
Completed	37
Not completed	0

Outcome measures

PrimaryEndorectal 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.

Time frame:: after 6 months of neoadjuvant chemotherapy.
Reported as:: Number · proportion of participants

Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy
proportion of participants	Chemotherapy
Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy	0.29 (0.16 to 0.45)

SecondaryPSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.

The rate of PSA decline by 50% compared to baseline PSA.

Time frame:: after 6 months of ajuvant chemotherapy.
Reported as:: Number · proportion of participants

PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.
proportion of participants	Chemotherapy
PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.	0.22 (0.11 to 0.38)

Adverse events

Collected over 6 months during the neoadjuvant chemotherapy.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Chemotherapy	—	11/41 (26.8%)	41/41 (100%)

Most frequent serious events

Most frequent serious events
Event	Chemotherapy
Febrile neutropeniaBlood and lymphatic system disorders	3/41
LymphopeniaInvestigations	3/41
NeutrophilsInvestigations	3/41
Allergic reactionImmune system disorders	1/41
Infection w/ unk ANC skin (cellulitis)Infections and infestations	1/41
LeukocytesInvestigations	1/41
HyperglycemiaMetabolism and nutrition disorders	1/41
CoughRespiratory, thoracic and mediastinal disorders	1/41

Most frequent other events

Showing 10 of 46

Most frequent other events
Event	Chemotherapy
HyperglycemiaMetabolism and nutrition disorders	37/41
FatigueGeneral disorders	33/41
Nose, hemorrhageRespiratory, thoracic and mediastinal disorders	22/41
AlopeciaSkin and subcutaneous tissue disorders	19/41
Taste disturbanceNervous system disorders	17/41
InsomniaPsychiatric disorders	16/41
TearingEye disorders	15/41
NauseaGastrointestinal disorders	15/41
Diarrhea w/o prior colostomyGastrointestinal disorders	12/41
Allergic rhinitisRespiratory, thoracic and mediastinal disorders	12/41

Baseline characteristics

42 enrolled, 1 participant withdrew before receiving treatment.

Age, Continuous
Age, Continuous(year)	Chemotherapy
Between 18 and 65 years	55 (41 to 67)

Sex: Female, Male
Sex: Female, Male(Participants)	Chemotherapy
Female	0
Male	41

Region of Enrollment
Region of Enrollment(participants)	Chemotherapy
United States	41

Study locations

3 sites

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

References and documents

Publications

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. PubMed 20818327 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00321646
Lead sponsor: Mary-Ellen Taplin, MD
Collaborators: Beth Israel Deaconess Medical Center, Duke University, Genentech, Inc., Sanofi
Responsible party: Mary-Ellen Taplin, MD (Assistant Professor of Medicine, HMS, Dana-Farber Cancer Institute) — Sponsor-investigator
First posted: May 4, 2006
Start date: Jun 2006
Primary completion: Nov 2008
Completion: Dec 2012
Results posted: Dec 25, 2013
Last update: May 16, 2016

Study contacts

Mary-Ellen Taplin, MD

principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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