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Prostate CancerNCT00499694

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

A study testing bevacizumab and satraplatin in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bevacizumab and satraplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
Oct 2007to Nov 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
bevacizumab, satraplatin
Keywords
stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called Avastin ®

    10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

  • satraplatinDrug

    80 mg/m(2), Orally, Days 1-5, every 35 days

Study groups in NCT00499694
Study groupRoleWhat they receive
Bevacizumab and SatraplatinExperimentalBevacizumab 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
Receives: Biological: bevacizumab; Drug: satraplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 70 days

Secondary outcomes (3)
  1. 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).

    Measured: Day 1 of every cycle (35 days) and Day 15 of every cycle

  2. 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

    Measured: Day 1 of every cycle (35 days) and Day 15 of every cycle

  3. Overall Survival

    Overall survival using the Kaplan-Meier method

    Measured: Followed every 3 months after treatment is discontinued

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00499694
Sponsor's protocol ID
CDR0000518085
Other IDs
P30CA022453, WSU-2006-118
Status last verified
May 2018
First submitted
10 Jul 2007
Last updated
12 Jun 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab and satraplatin in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (time frame: Every 70 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.

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