Clinical trial NCT00499694: Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
Official title: Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer
recurrent prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Time to Progression
timeFrame: Every 70 days
Secondary outcomes:
measure: Toxicity, Presented as the Number of Participants With Adverse Events
timeFrame: Day 1 of every cycle (35 days) and Day 15 of every cycle
measure: Percentage of Participants With Prostate-specific Antigen (PSA) Response
timeFrame: Day 1 of every cycle (35 days) and Day 15 of every cycle
measure: Overall Survival
timeFrame: Followed every 3 months after treatment is discontinued
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Veterans Affairs Medical Center - Detroit
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ulka N. Vaishampayan, MD
role: STUDY_CHAIR
References: