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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00499694
• Date of registration: 10/07/2007
• Primary sponsor: Barbara Ann Karmanos Cancer Institute
• Public title: Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
• Scientific title: Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
• Date of first enrolment: October 2007
• Target sample size: 31
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00499694
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ulka N. Vaishampayan, MD
• Affiliation: Barbara Ann Karmanos Cancer Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Biological: bevacizumab

Drug: satraplatin

Primary Outcome(s)

Time to progression [Time Frame: Every 70 days]

Secondary Outcome(s)

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]

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]

Overall survival [Time Frame: Followed every 3 months after treatment is discontinued]

Prostate-specific antigen (PSA) response rate [Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle]

Toxicity [Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle]

Secondary ID(s)

CDR0000518085

P30CA022453

WSU-2006-118

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)