Trial Outcomes & Findings for Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy (NCT NCT00321646)
NCT ID: NCT00321646
Last Updated: 2016-05-16
Results Overview
A response was defined as a decrease in tumor size of \>50% for the largest lesion in the prostate by endorectal MRI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
after 6 months of neoadjuvant chemotherapy.
Results posted on
2016-05-16
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).
No subjects were found to be ineligible after signing the informed consent form and registering with the QACT.
Participant milestones
| Measure |
Chemotherapy
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Neoadjuvant Chemotherapy
STARTED
|
42
|
|
Neoadjuvant Chemotherapy
COMPLETED
|
38
|
|
Neoadjuvant Chemotherapy
NOT COMPLETED
|
4
|
|
Prostatectomy
STARTED
|
37
|
|
Prostatectomy
COMPLETED
|
37
|
|
Prostatectomy
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Chemotherapy
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Neoadjuvant Chemotherapy
Withdrawal by Subject
|
1
|
|
Neoadjuvant Chemotherapy
Adverse Event
|
2
|
|
Neoadjuvant Chemotherapy
Disease progression
|
1
|
Baseline Characteristics
Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=41 Participants
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Age, Continuous
Between 18 and 65 years
|
55 year
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 6 months of neoadjuvant chemotherapy.A response was defined as a decrease in tumor size of \>50% for the largest lesion in the prostate by endorectal MRI.
Outcome measures
| Measure |
Chemotherapy
n=41 Participants
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy
|
0.29 proportion of participants
Interval 0.16 to 0.45
|
SECONDARY outcome
Timeframe: after 6 months of ajuvant chemotherapy.The rate of PSA decline by 50% compared to baseline PSA.
Outcome measures
| Measure |
Chemotherapy
n=41 Participants
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.
|
0.22 proportion of participants
Interval 0.11 to 0.38
|
Adverse Events
Chemotherapy
Serious events: 11 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy
n=41 participants at risk
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
2.4%
1/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
Leukocytes
|
2.4%
1/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
Lymphopenia
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
Neutrophils
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • 6 months during the neoadjuvant chemotherapy.
|
Other adverse events
| Measure |
Chemotherapy
n=41 participants at risk
docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
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.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
90.2%
37/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Fatigue
|
80.5%
33/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
53.7%
22/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.3%
19/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Nervous system disorders
Taste disturbance
|
41.5%
17/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Psychiatric disorders
Insomnia
|
39.0%
16/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Eye disorders
Tearing
|
36.6%
15/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Nausea
|
36.6%
15/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
29.3%
12/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
29.3%
12/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
26.8%
11/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
26.8%
11/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
26.8%
11/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
24.4%
10/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Nervous system disorders
Neuropathy-sensory
|
24.4%
10/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Nervous system disorders
Head/headache
|
22.0%
9/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Constipation
|
19.5%
8/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
19.5%
8/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
AST, SGOT
|
19.5%
8/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.5%
8/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Eye disorders
Vision-blurred
|
17.1%
7/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
17.1%
7/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
17.1%
7/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.6%
6/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Fever w/o neutropenia
|
14.6%
6/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Immune system disorders
Allergic reaction
|
12.2%
5/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
5/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Vascular disorders
Hypertension
|
12.2%
5/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
Lymphopenia
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
9.8%
4/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Eye disorders
Ocular-other
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Rigors/chills
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Edema limb
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Pain NOS
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
General disorders
Pain-other
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Investigations
ALT, SGPT
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
|
Psychiatric disorders
Depression
|
7.3%
3/41 • 6 months during the neoadjuvant chemotherapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place