Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab. Secondary Determine the toxicity of this regimen in these patients. Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen. Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen. 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.

Official Title
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Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: bevacizumab
* Drug: satraplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: Metastatic disease Objective progression or rising prostate-specific antigen (PSA) despite androgen-deprivation therapy and antiandrogen withdrawal Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week Minimum PSA of 5 ng/mL or new areas of bony metastases on bone scan required if no measurable disease No minimum PSA for measurable disease 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) Concurrent luteinizing-hormone releasing-hormone agonist allowed to maintain 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: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia No psychiatric illness or social situation that would preclude compliance with study requirements No HIV positivity No immune deficiency PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior flutamide More than 6 weeks since prior bicalutamide or nilutamide At least 4 weeks since prior radiotherapy At least 2 weeks since prior minor surgery More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device) More than 28 days since prior major surgery or open biopsy (8 weeks if high-risk procedure such as liver resection, thoracotomy, or neurosurgery) Concurrent low-dose aspirin (≤ 325 mg/day) allowed Concurrent anticoagulants allowed if patient has been on therapy ≥ 4 weeks and has no acute thromboembolic activity No concurrent major surgery No concurrent aprepitant No concurrent immunosuppressive therapy No concurrent combination anti-retroviral therapy for HIV-positive patients No other concurrent antitumor therapy (including radiotherapy) No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab and Satraplatin<br>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 | Biological: bevacizumab<br>* 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)<br>* Other names: Avastin ®;Drug: satraplatin<br>* 80 mg/m(2), Orally, Days 1-5, every 35 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate