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Phase II Study of Itraconazole in Castration Resistant Prostate Cancer (CRPC) Post Docetaxel Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Metastatic Disease

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Trial Information

Phase II Study of Itraconazole in Castration Resistant Prostate Cancer (CRPC) Post Docetaxel Chemotherapy


Inclusion Criteria:



Each patient must meet the following criteria to be enrolled in this study.

1. Willing and able to provide written informed consent

2. Male aged >=18 years

3. Histologically or cytologically confirmed adenocarcinoma of the prostate

4. Metastatic disease or prior history of metastases documented by positive bone scan or
metastatic lesions on CT or MRI

5. Prostate cancer progression documented by PSA according to PCWG2 or radiographic
progression according to RECIST criteria version 1.1

6. Must have had progression during or after docetaxel based chemotherapy.

7. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
If the patient is currently being treated with LHRH agonists (patient who have not
undergone an orchiectomy), this therapy must have been initiated at least 4 weeks
prior to Cycle 1 Day 1 and treatment must be continued throughout the study.

8. Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2

9. Hemoglobin >= 10.0 g/dL

10. Platelet count >=100,000 microliters

11. Serum creatinine <= 2 or a calculated creatinine clearance >= 40 mL/min

12. Liver function:

i. Serum bilirubin < 1.5 x ULN (except for patients Gilbert's disease) ii. AST or
ALT < 2.5 x ULN

13. Able to swallow the study drug whole as a tablet

14. Life expectancy of at least 6 months

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Known brain metastasis

2. Radiation therapy within 4 weeks of Cycle 1, Day 1

3. Prior systemic treatment with an azole drug (e.g. fluconazole, ketoconazole) within
4weeks of Cycle 1, Day 1

4. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose
PSA did not decline for three or more months in response to antiandrogen given as a
second line or later intervention will require only a two week washout prior to Cycle
1,Day 1) Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1
Day 1 (patients whose PSA did not decline for three or more months in response to
antiandrogen given as a second line or later intervention will require only a two
week washout prior to Cycle 1 Day 1)

5. Known active or symptomatic viral hepatitis or chronic liver disease

6. Clinically significant heart disease as evidenced by myocardial infarction or
arterial thrombotic events in the past 6 months; severe or unstable angina

7. Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of
recurrence within 24 months

8. Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

9. Any condition which, in the opinion of the investigator, would preclude the patient's
participation in this trial.

10. No more than 3 prior chemotherapy regimens.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serum PSA measured after 12 weeks is the study endpoint. If after 10 patients <2 have a response, the study will be halted.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PROS0037

NCT ID:

NCT01450683

Start Date:

September 2010

Completion Date:

April 2011

Related Keywords:

  • Prostate Cancer
  • Metastatic Disease
  • Neoplasm Metastasis
  • Prostatic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317