AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

This is an interventional treatment trial for Hormone-resistant Prostate Cancer Read More

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