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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00499694
First received: July 10, 2007
Last updated: August 9, 2014
Last verified: August 2014

July 10, 2007
August 9, 2014
October 2007
November 2012   (final data collection date for primary outcome measure)
Time to Progression [ Time Frame: Every 70 days ] [ Designated as safety issue: No ]
Time to progression
Complete list of historical versions of study NCT00499694 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ] [ Designated as safety issue: Yes ]
  • Prostate-specific Antigen (PSA) Response Rate [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Followed every 3 months after treatment is discontinued ] [ Designated as safety issue: No ]
  • Changes in Levels of N-terminal Collagen Peptide (NTX) and Bone-specific Alkaline Phosphatase (BSAP) [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ] [ Designated as safety issue: No ]
  • Correlation of Urine NTX and Serum BSAP Levels With Time to Progression [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ] [ Designated as safety issue: No ]
  • Toxicity
  • Prostate-specific antigen (PSA) response rate
  • Overall survival
  • Changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP)
  • Correlation of urine NTX and serum BSAP levels with time to progression
Not Provided
Not Provided
 
Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer

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

  • 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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Biological: bevacizumab
    10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
    Other Name: Avastin ®
  • Drug: satraplatin
    80 mg/m(2), Orally, Days 1-5, every 35 days
Experimental: 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

Interventions:
  • Biological: bevacizumab
  • Drug: satraplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00499694
CDR0000518085, P30CA022453, WSU-2006-118
Yes
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP