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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: bevacizumab; Drug: satraplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted11 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
- Investigators
- Ulka N. Vaishampayan, MD, Study chair, Barbara Ann Karmanos Cancer Institute
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00499694
- Acronym / sponsor ID
- CDR0000518085
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and Satraplatin | Experimental | Biological: bevacizumab, Drug: satraplatinBevacizumab 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabAlso: Avastin ®10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) | Biological | Bevacizumab and Satraplatin |
| satraplatin80 mg/m(2), Orally, Days 1-5, every 35 days | Drug | Bevacizumab and Satraplatin |
Primary outcome
Time to Progression
Time frame: Every 70 days
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.
3 secondary outcomes
Toxicity, Presented as the Number of Participants With Adverse Events
Time frame: Day 1 of every cycle (35 days) and Day 15 of every cycle
Percentage of Participants With Prostate-specific Antigen (PSA) Response
Time frame: Day 1 of every cycle (35 days) and Day 15 of every cycle
Overall Survival
Time frame: Followed every 3 months after treatment is discontinued
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulka N. Vaishampayan, MD study chair
Barbara Ann Karmanos Cancer Institute
2 sites in 1 country: see every site and its status.
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.