Primary Eligibility:
- Histologically confirmed metastatic prostate cancer; progressive, androgen-independent disease:
- Radiographic evidence of disease that has continued to progress despite hormonal agents
- Patients on flutamide must have disease progression at least 4 weeks after withdrawal
- Patients on bicalutamide or nilutamide must have disease progression at least 6 weeks after withdrawal
- Progressive disease requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostate-specific antigen is continuing to rise on successive measurements
- Must have received prior docetaxel for androgen-independent prostate cancer
- Concurrent gonadotropin-releasing hormone agonists or antagonists required for patients without bilateral surgical castration
- No known brain metastases
- ECOG 0–2
- Absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3; hemoglobin ≥ 8 g/dL
- Bilirubin normal (unless due to clinical Gilbert’s syndrome); AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine OR creatinine clearance normal; urine protein ≤ +1 on two consecutive dipsticks taken no less than 1 week apart
- Blood pressure < 140/90 mm Hg
- No concurrent antiretroviral therapy for HIV-positive patients
- No uncontrolled intercurrent illness including, but not limited to, any of the following: hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit compliance
Treatment Plan:
- Patients receive oral AZD2171 in addition to prednisone once daily on Days 1–28
- Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
- Blood samples are collected at baseline and periodically during Course 1 of study therapy
- Patients undergo a dynamic contrast-enhanced MRI at baseline and on Days 2, 28, 56, after Cycle 4, and then every four cycles
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers
Reviewed: 6/2/08
Updated: 12/5/08
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