Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 1542 for:    Androgens

Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776594
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : August 23, 2016
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Androgen Deprivation Therapy
Drug: bicalutamide
Drug: bevacizumab
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy Alone
Hide Arm/Group Description

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Period Title: Overall Study
Started 66 36
Completed 62 34
Not Completed 4 2
Arm/Group Title Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy Alone Total
Hide Arm/Group Description

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 66 36 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 66 participants 36 participants 102 participants
66
(60 to 69)
63
(60 to 68)
65
(65 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 36 participants 102 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
66
 100.0%
36
 100.0%
102
 100.0%
1.Primary Outcome
Title Relapse-free Survival
Hide Description To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Overall Number of Participants Analyzed 66 36
Median (95% Confidence Interval)
Unit of Measure: months
13
(11 to 15)
10
(10 to 12)
2.Secondary Outcome
Title Number of Participants With PSA <0.2 ng/ml at Six Months
Hide Description Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
Time Frame Six months (at completion of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Overall Number of Participants Analyzed 64 35
Measure Type: Number
Unit of Measure: Number of participants
51 27
3.Secondary Outcome
Title Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
Hide Description The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Overall Number of Participants Analyzed 65 36
Measure Type: Number
Unit of Measure: participants
48 13
4.Secondary Outcome
Title Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Hide Description Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Level in Patients Treated With ADT+Bev Leptin in Patients Treated With ADT Alone
Hide Arm/Group Description:
Leptin level in patients with sample available treated with ADT+bev
Leptin in patients with sample available treated with ADT alone
Overall Number of Participants Analyzed 43 21
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
13755
(6570 to 25762)
10179
(6924 to 15333)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 2 Group 1
Hide Arm/Group Description

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

All-Cause Mortality
Group 2 Group 1
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 2 Group 1
Affected / at Risk (%) Affected / at Risk (%)
Total   5/36 (13.89%)   18/66 (27.27%) 
Cardiac disorders     
Cardiac-ischemia  1  0/36 (0.00%)  1/66 (1.52%) 
Gastrointestinal disorders     
Diarrhea w/o prior colostomy  1  0/36 (0.00%)  1/66 (1.52%) 
Vomiting  1  0/36 (0.00%)  1/66 (1.52%) 
Infections and infestations     
Infection w/ unk ANC peritoneal cavity  1  0/36 (0.00%)  1/66 (1.52%) 
Infection w/ unk ANC ungual (nails)  1  0/36 (0.00%)  1/66 (1.52%) 
Metabolism and nutrition disorders     
Hyperglycemia  1  0/36 (0.00%)  1/66 (1.52%) 
Hyponatremia  1  0/36 (0.00%)  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal/soft tissue-other  1  1/36 (2.78%)  1/66 (1.52%) 
Nervous system disorders     
Syncope  1  1/36 (2.78%)  1/66 (1.52%) 
Head/headache  1  0/36 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm- wheezing  1  0/36 (0.00%)  1/66 (1.52%) 
Dyspnea  1  1/36 (2.78%)  0/66 (0.00%) 
Vascular disorders     
Hypertension  1  2/36 (5.56%)  13/66 (19.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 2 Group 1
Affected / at Risk (%) Affected / at Risk (%)
Total   32/36 (88.89%)   63/66 (95.45%) 
Blood and lymphatic system disorders     
Bone marrow cellularity  1  0/36 (0.00%)  1/66 (1.52%) 
Hemoglobin  1  3/36 (8.33%)  3/66 (4.55%) 
Lymphatics-other  1  0/36 (0.00%)  1/66 (1.52%) 
Cardiac disorders     
Sinus bradycardia  1  0/36 (0.00%)  1/66 (1.52%) 
Arrhythmia-other  1  0/36 (0.00%)  1/66 (1.52%) 
Endocrine disorders     
Hyopthyroidism  1  0/36 (0.00%)  1/66 (1.52%) 
Endocrine-other  1  0/36 (0.00%)  1/66 (1.52%) 
Eye disorders     
Neuropathy CN II vision  1  0/36 (0.00%)  1/66 (1.52%) 
Glaucoma  1  1/36 (2.78%)  0/66 (0.00%) 
Vision-blurred  1  0/36 (0.00%)  1/66 (1.52%) 
Ocular-other  1  1/36 (2.78%)  1/66 (1.52%) 
Gastrointestinal disorders     
Constipation  1  1/36 (2.78%)  9/66 (13.64%) 
Dentures or dental prosthesis  1  0/36 (0.00%)  1/66 (1.52%) 
Diarrhea w/o prior colostomy  1  1/36 (2.78%)  5/66 (7.58%) 
Dry mouth  1  0/36 (0.00%)  1/66 (1.52%) 
Dysphagia  1  0/36 (0.00%)  1/66 (1.52%) 
Esophagitis  1  0/36 (0.00%)  1/66 (1.52%) 
Fistula- Anus  1  0/36 (0.00%)  1/66 (1.52%) 
Flatulence  1  0/36 (0.00%)  1/66 (1.52%) 
Gastritis  1  0/36 (0.00%)  1/66 (1.52%) 
Hemorrhoids  1  0/36 (0.00%)  1/66 (1.52%) 
Incontinence- anal  1  1/36 (2.78%)  1/66 (1.52%) 
Muco/stomatitis by exam- oral cavity  1  0/36 (0.00%)  2/66 (3.03%) 
Muco/stomatitis (symptom) oral cavity  1  0/36 (0.00%)  2/66 (3.03%) 
Muco/stomatitis (symptom) stomach  1  0/36 (0.00%)  1/66 (1.52%) 
Nausea  1  0/36 (0.00%)  2/66 (3.03%) 
Salivary  1  0/36 (0.00%)  1/66 (1.52%) 
Ulcer- duodenum  1  0/36 (0.00%)  1/66 (1.52%) 
GI-other  1  1/36 (2.78%)  2/66 (3.03%) 
Lower GI- hemorrhage NOS  1  2/36 (5.56%)  2/66 (3.03%) 
Oral cavity- hemorrhage  1  0/36 (0.00%)  4/66 (6.06%) 
Rectum- hemorrhage  1  0/36 (0.00%)  1/66 (1.52%) 
Abdomen- pain  1  0/36 (0.00%)  2/66 (3.03%) 
Anus- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Oral cavity- pain  1  0/36 (0.00%)  1/66 (1.52%) 
General disorders     
Fatigue  1  8/36 (22.22%)  38/66 (57.58%) 
Fever w/o neutropenia  1  0/36 (0.00%)  2/66 (3.03%) 
Rigors/chills  1  0/36 (0.00%)  1/66 (1.52%) 
Constitutional- other  1  0/36 (0.00%)  3/66 (4.55%) 
Injection site reaction  1  0/36 (0.00%)  3/66 (4.55%) 
Edema head and neck  1  0/36 (0.00%)  1/66 (1.52%) 
Edema limb  1  2/36 (5.56%)  4/66 (6.06%) 
Extremity-lower (gait/walking)  1  1/36 (2.78%)  0/66 (0.00%) 
Chest/thoracic pain NOS  1  0/36 (0.00%)  2/66 (3.03%) 
Pain-other  1  0/36 (0.00%)  6/66 (9.09%) 
Immune system disorders     
Allergy-other  1  0/36 (0.00%)  1/66 (1.52%) 
Infections and infestations     
Infection Gr0-2 neut- bronchus  1  0/36 (0.00%)  1/66 (1.52%) 
Infection Gr0-2 neut- oral cavity  1  0/36 (0.00%)  1/66 (1.52%) 
Infection Gr0-2 neut- sinus  1  0/36 (0.00%)  2/66 (3.03%) 
Infection Gr0-2 neut- upper airway  1  0/36 (0.00%)  1/66 (1.52%) 
Infection Gr0-2 neut- urinary tract  1  0/36 (0.00%)  1/66 (1.52%) 
Infection w/ unk ANC oral cavity/gums  1  0/36 (0.00%)  1/66 (1.52%) 
Infection w/ unk ANC sinus  1  0/36 (0.00%)  1/66 (1.52%) 
Infection w/ unk ANC urinary tract NOS  1  0/36 (0.00%)  1/66 (1.52%) 
Infection-other  1  0/36 (0.00%)  2/66 (3.03%) 
Injury, poisoning and procedural complications     
Bruising  1  1/36 (2.78%)  1/66 (1.52%) 
Intra-op injury Face NOS  1  0/36 (0.00%)  1/66 (1.52%) 
Investigations     
Leukocytes  1  1/36 (2.78%)  0/66 (0.00%) 
Lymphopenia  1  0/36 (0.00%)  2/66 (3.03%) 
Platelets  1  0/36 (0.00%)  3/66 (4.55%) 
Weight gain  1  1/36 (2.78%)  0/66 (0.00%) 
Weight loss  1  0/36 (0.00%)  2/66 (3.03%) 
Alkaline phosphatase  1  0/36 (0.00%)  1/66 (1.52%) 
ALT- SGPT  1  2/36 (5.56%)  4/66 (6.06%) 
AST- SGOT  1  2/36 (5.56%)  5/66 (7.58%) 
Bilirubin  1  0/36 (0.00%)  1/66 (1.52%) 
Hypercholesterolemia  1  1/36 (2.78%)  4/66 (6.06%) 
Creatinine  1  0/36 (0.00%)  6/66 (9.09%) 
Metabolism and nutrition disorders     
Anorexia  1  0/36 (0.00%)  3/66 (4.55%) 
Hypoalbuminemia  1  1/36 (2.78%)  0/66 (0.00%) 
Hyperglycemia  1  0/36 (0.00%)  2/66 (3.03%) 
Hyperkalemia  1  0/36 (0.00%)  3/66 (4.55%) 
Hypokalemia  1  0/36 (0.00%)  2/66 (3.03%) 
Hyponatremia  1  0/36 (0.00%)  2/66 (3.03%) 
Hypertriglyceridemia  1  1/36 (2.78%)  5/66 (7.58%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/36 (0.00%)  4/66 (6.06%) 
Extremity upper (function)  1  0/36 (0.00%)  1/66 (1.52%) 
Joint-function  1  0/36 (0.00%)  2/66 (3.03%) 
Nonneuropathic lower extr muscle weak  1  0/36 (0.00%)  1/66 (1.52%) 
Nonneuropathic upper extr muscle weak  1  0/36 (0.00%)  1/66 (1.52%) 
Nonneuropathic generalized weakness  1  1/36 (2.78%)  2/66 (3.03%) 
Musculoskeletal/soft tissue-other  1  1/36 (2.78%)  1/66 (1.52%) 
Back- pain  1  2/36 (5.56%)  5/66 (7.58%) 
Buttock- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Chest wall- pain  1  0/36 (0.00%)  2/66 (3.03%) 
Extremity-limb- pain  1  1/36 (2.78%)  9/66 (13.64%) 
Joint- pain  1  2/36 (5.56%)  15/66 (22.73%) 
Muscle- pain  1  0/36 (0.00%)  6/66 (9.09%) 
Neck- pain  1  0/36 (0.00%)  2/66 (3.03%) 
Nervous system disorders     
Taste disturbance  1  0/36 (0.00%)  2/66 (3.03%) 
Ataxia  1  0/36 (0.00%)  1/66 (1.52%) 
Cognitive disturbance  1  1/36 (2.78%)  2/66 (3.03%) 
Dizziness  1  2/36 (5.56%)  5/66 (7.58%) 
Memory impairment  1  0/36 (0.00%)  1/66 (1.52%) 
Neuropathy CN IX pharynx ear tongue  1  0/36 (0.00%)  1/66 (1.52%) 
Neuropathy-sensory  1  0/36 (0.00%)  11/66 (16.67%) 
Neurologic-other  1  0/36 (0.00%)  2/66 (3.03%) 
Head/headache  1  2/36 (5.56%)  28/66 (42.42%) 
Neuropathic- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Psychiatric disorders     
Insomnia  1  1/36 (2.78%)  7/66 (10.61%) 
Confusion  1  0/36 (0.00%)  1/66 (1.52%) 
Agitation  1  0/36 (0.00%)  2/66 (3.03%) 
Anxiety  1  0/36 (0.00%)  1/66 (1.52%) 
Depression  1  1/36 (2.78%)  2/66 (3.03%) 
Libido  1  1/36 (2.78%)  0/66 (0.00%) 
Renal and urinary disorders     
Bladder- hemorrhage  1  0/36 (0.00%)  1/66 (1.52%) 
Urinary hemorrhage NOS  1  1/36 (2.78%)  2/66 (3.03%) 
Hemoglobinuria  1  0/36 (0.00%)  1/66 (1.52%) 
Proteinuria  1  0/36 (0.00%)  7/66 (10.61%) 
Incontinence urinary  1  1/36 (2.78%)  3/66 (4.55%) 
Urinary frequency/urgency  1  4/36 (11.11%)  15/66 (22.73%) 
Urinary retention  1  0/36 (0.00%)  1/66 (1.52%) 
Renal/GU-other  1  1/36 (2.78%)  2/66 (3.03%) 
Reproductive system and breast disorders     
Scrotum- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Erectile impotence  1  0/36 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/36 (0.00%)  4/66 (6.06%) 
Muco/stomatitis by exam- larynx  1  0/36 (0.00%)  1/66 (1.52%) 
Nose- hemorrhage  1  1/36 (2.78%)  15/66 (22.73%) 
Throat/pharynx/larynx- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Cough  1  1/36 (2.78%)  5/66 (7.58%) 
Dyspnea  1  0/36 (0.00%)  2/66 (3.03%) 
Nasal cavity/paranasal sinus reaction  1  1/36 (2.78%)  1/66 (1.52%) 
Obstruction- airway-bronchus  1  0/36 (0.00%)  1/66 (1.52%) 
Voice changes/dysarthria  1  0/36 (0.00%)  10/66 (15.15%) 
Pulmonary/Upper Respiratory-other  1  0/36 (0.00%)  5/66 (7.58%) 
Skin and subcutaneous tissue disorders     
Sweating  1  2/36 (5.56%)  3/66 (4.55%) 
Dry skin  1  0/36 (0.00%)  6/66 (9.09%) 
Alopecia  1  1/36 (2.78%)  1/66 (1.52%) 
Hyperpigmentation  1  0/36 (0.00%)  1/66 (1.52%) 
Pruritus/itching  1  0/36 (0.00%)  2/66 (3.03%) 
Rash/desquamation  1  1/36 (2.78%)  2/66 (3.03%) 
Rash: acne/acneiform  1  0/36 (0.00%)  1/66 (1.52%) 
Skin-other  1  1/36 (2.78%)  5/66 (7.58%) 
Scalp- pain  1  0/36 (0.00%)  1/66 (1.52%) 
Vascular disorders     
Hypertension  1  0/36 (0.00%)  19/66 (28.79%) 
Hot flashes  1  25/36 (69.44%)  42/66 (63.64%) 
Hemorrhage-other  1  0/36 (0.00%)  1/66 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary-Ellen Taplin, MD
Organization: Dana Farber Cancer Institute
Phone: 617-632-6328
EMail: Mary_taplin@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00776594     History of Changes
Obsolete Identifiers: NCT01019031
Other Study ID Numbers: 08-190
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: July 29, 2015
Results First Posted: August 23, 2016
Last Update Posted: October 21, 2016