This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC). II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530. III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population. OUTLINE: This is a multicenter study. Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given orally
Correlative studies
City of Hope
Duarte, California, United States
PSA Response Rate
Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR
Time frame: PSA measured every 4 weeks
Progression-free Survival (PFS)
PFS defined as time between start of treatment and disease progression or death. Using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From start of treatment until progression or death, up to 2 years
Time to Treatment Failure
Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From first day of treatment until discontinuation of treatment, up to 2 years
Overall Survival
Estimated using the product-limit method of Kaplan and Meier.
Time frame: From start of treatment, up to 5 years
Toxicity Data
Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.
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Time frame: Up to 2 years
Relationship Between Changes in Laboratory Correlates and Response and Survival
Time frame: Up to 2 years
N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers
Time frame: At baseline, at 6 hours, at each course (day 1), and at 2 years