Clinical trial NCT00513071: AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Official title: A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-08-08
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PSA Response Rate
timeFrame: PSA measured every 4 weeks
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From start of treatment until progression or death, up to 2 years
measure: Time to Treatment Failure
timeFrame: From first day of treatment until discontinuation of treatment, up to 2 years
measure: Overall Survival
timeFrame: From start of treatment, up to 5 years
measure: Toxicity Data
timeFrame: Up to 2 years
measure: Relationship Between Changes in Laboratory Correlates and Response and Survival
timeFrame: Up to 2 years
measure: N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers
timeFrame: At baseline, at 6 hours, at each course (day 1), and at 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Primo Lara
role: PRINCIPAL_INVESTIGATOR
References: