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Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

Every 70 days

Safety Issue:

No

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000518085

NCT ID:

NCT00499694

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932