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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Duke University | OTHER |
| Genentech, Inc. | INDUSTRY |
| Sanofi |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy | Experimental | docetaxel and bevacizumab prior to prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy. | The rate of PSA decline by 50% compared to baseline PSA. | after 6 months of ajuvant chemotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20818327 | Derived | 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. |
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No subjects were found to be ineligible after signing the informed consent form and registering with the QACT.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Neoadjuvant Chemotherapy |
|
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| INDUSTRY |
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|
|
| Docetaxel | Drug | Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter. |
|
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Prostatectomy |
|
42 enrolled, 1 participant withdrew before receiving treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | year |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | after 6 months of neoadjuvant chemotherapy. |
|
|
| ||||||||||||||||||||||||||
| Secondary | PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy. | The rate of PSA decline by 50% compared to baseline PSA. | Posted | Number | 95% Confidence Interval | proportion of participants | after 6 months of ajuvant chemotherapy. |
|
|
6 months during the neoadjuvant chemotherapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 11 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | 617-582-8313 | mary_taplin@dfci.harvard.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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|