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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2006-118 | Other Identifier | Barbara Ann Karmanos Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 28-42 days.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab and Satraplatin | Experimental | Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit. | Every 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity, Presented as the Number of Participants With Adverse Events | Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0). | Day 1 of every cycle (35 days) and Day 15 of every cycle |
| Percentage of Participants With Prostate-specific Antigen (PSA) Response |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week
Must have received ≤ 1 prior docetaxel-based chemotherapy for metastatic disease
No known CNS disease or brain metastases
Testosterone < 0.5 ng/mL (castrate level)
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8.0 g/dL
Bilirubin normal
Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min
Urine protein:creatinine ratio ≤ 1.0 OR proteinuria ≤ 2+ by urine dipstick OR ≤ 1 g protein/24-hour urine collection
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
No significant traumatic injury within the past 28 days
Adequately controlled hypertension (defined as systolic blood pressure [BP] ≤ 150 mm Hg and/or diastolic BP ≤ 100 mm Hg on antihypertensive medications)
No history of hypertensive crisis or hypertensive encephalopathy
No New York Heart Association class II-IV congestive heart failure
No myocardial infarction or unstable angina within the past 6 months
No stroke or transient ischemic attack within the past 6 months
No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
No symptomatic peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No prior malignancy except adequately treated skin cancer or any other cancer in complete remission for ≥ 2 years
Able to swallow and retain capsules
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No serious nonhealing wound, ulcer, or bone fracture
No known hypersensitivity to any component of bevacizumab
No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
No psychiatric illness or social situation that would preclude compliance with study requirements
No HIV positivity
No immune deficiency
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States | ||
| Veterans Affairs Medical Center - Detroit |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab and Satraplatin | Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab and Satraplatin | Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Progression | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit. | Posted | Median | 90% Confidence Interval | months | Every 70 days |
|
|
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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 | Bevacizumab and Satraplatin | Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Small sample size, correlative ERCC testing conducted in only a subset of patients (14 of 30 pts) and the findings of this study are hypothesis generating however validation in larger sample size would be needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulka Vaishampayan, M.D. | Barbara Ann Karmanos Cancer Institute | (313) 576-8718 | vaishamu@karmanos.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C081294 | satraplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| satraplatin | Drug | 80 mg/m(2), Orally, Days 1-5, every 35 days |
|
Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels |
| Day 1 of every cycle (35 days) and Day 15 of every cycle |
| Overall Survival | Overall survival using the Kaplan-Meier method | Followed every 3 months after treatment is discontinued |
| Detroit |
| Michigan |
| 48201 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Toxicity, Presented as the Number of Participants With Adverse Events | Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0). | Posted | Count of Participants | Participants | Day 1 of every cycle (35 days) and Day 15 of every cycle |
|
|
|
| Secondary | Percentage of Participants With Prostate-specific Antigen (PSA) Response | Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels | Posted | Number | 90% Confidence Interval | pct. of pts. with 50%+ decrease in PSA | Day 1 of every cycle (35 days) and Day 15 of every cycle |
|
|
|
| Secondary | Overall Survival | Overall survival using the Kaplan-Meier method | Posted | Median | 90% Confidence Interval | months | Followed every 3 months after treatment is discontinued |
|
|
|
| 7 |
| 30 |
| 21 |
| 30 |
| Leukeopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis_PE | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bloating Distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bloating Distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|
|
| Leukopenia |
|
| Neutropenia |
|
| Anemia |
|
| Edema |
|
| Dehydration |
|
| Hyperglycemia |
|
| Thrombocytopenia |
|
| Proteinuria |
|
| Hypertension |
|
| Fatigue |
|
| Hypokalemia |
|
| Hyponatremia |
|
| hypomagnesemia |
|
| AST |
|
| Creatinine |
|
| Constipation |
|
| Bloating/Distention |
|
| Fever/Rigors |
|
| Dyspepsia |
|
| Weight Loss |
|
| Anorexia |
|
| Allergic Reaction |
|