Inclusion Criteria:
- Histologically or cytologically confirmed prostate cancer with a Gleason score
available or interpretable and meeting 1 of the following criteria:
- No prior chemotherapy and relatively minimal cancer spread
- Only one prior taxane-based chemotherapy for aggressive and/or symptomatic
disease
- Must have prostate cancer considered to be hormone refractory or androgen independent
by one or more of the following criteria (despite androgen deprivation and
anti-androgen withdrawal when applicable):
- Progression of unidimensionally measurable disease assessed within 28 days prior
to initial administration of drug
- Progression of evaluable but not measurable disease assessed within 28 days
prior to initial administration of drug for PSA evaluation and within 42 days
for imaging studies (e.g., bone scans)
- Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and
non-target lesions (e.g., PSA level) assessed within 28 days prior to initial
administration of drug
- Measurable disease is not required but is allowed
- Must be surgically or medically castrated
- If the method of castration was luteinizing hormone-releasing hormone (LHRH)
agonists (e.g., leuprolide or goserelin), then the patient must be willing to
continue the use of LHRH agonists
- Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months
prior to registration
- ECOG performance status 0-2
- WBC >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin > 9 g/d
- Total bilirubin within normal institutional limits
- AST/ALT =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
- Must agree to use adequate contraception prior to study entry and for the duration of
study participation
- At least 3 weeks since the completion of chemotherapy and radiotherapy and the
patient must have recovered from the side effects of the therapy
- At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days
for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and
demonstrated progression of disease since the agents were suspended
- Concurrent bisphosphonate therapy is allowed
Exclusion Criteria:
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530
- Patients with any of the following conditions that impair the ability to swallow
AZD0530 tablets
- Gastrointestinal tract disease resulting in an inability to take oral medication
or requiring IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements
- Patients who have not recovered from adverse events due to agents administered more
than 4 weeks earlier
- Use of specifically prohibited CYP3A4-active agents or substances
- Prohibited drugs should be discontinued 7 days prior to the administration of
the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
- Patients receiving any other investigational agents
- No investigational or commercial agents or therapies other than study drugs may be
administered with the intent to treat the patient's malignancy
- HIV-positive patients on combination antiretroviral therapy