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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499694
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: bevacizumab
Drug: satraplatin

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Docetaxel    Bevacizumab    JM 216   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Satraplatin and Docetaxel in Androgen Independent Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Prostate-specific antigen (PSA) response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) [ Designated as safety issue: No ]
  • Correlation of urine NTX and serum BSAP levels with time to progression [ Designated as safety issue: No ]

Estimated Enrollment:   24
Study Start Date:   October 2007
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499694

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute     Recruiting
      Detroit, Michigan, United States, 48201-1379
      Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Sinai-Grace Hospital     Recruiting
      Detroit, Michigan, United States, 48235
      Contact: Ulka N. Vaishampayan     313-576-8718        
Veterans Affairs Medical Center - Detroit     Recruiting
      Detroit, Michigan, United States, 48201
      Contact: Contact Person     313-576-1000        

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Ulka N. Vaishampayan, MD     Barbara Ann Karmanos Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000518085, WSU-2006-118
First Received:   July 10, 2007
Last Updated:   August 26, 2008
ClinicalTrials.gov Identifier:   NCT00499694
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer  
recurrent prostate cancer  
adenocarcinoma of the prostate  

Study placed in the following topic categories:
Docetaxel
Satraplatin
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Bevacizumab
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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