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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT01450683
First received: September 30, 2011
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

Assess the efficacy of itraconazole as an anticancer drug in CRPC as measured by a drop in serum PSA


Condition Intervention Phase
Prostate Cancer
Metastatic Disease
Drug: Itraconazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Itraconazole in Castration Resistant Prostate Cancer (CRPC) Post Docetaxel Chemotherapy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Serum PSA measured after 12 weeks is the study endpoint. If after 10 patients <2 have a response, the study will be halted. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole Drug: Itraconazole
600 mg oral
Other Name: Sporanox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450683

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01450683     History of Changes
Other Study ID Numbers: PROS0037, SU-12032010-7271
Study First Received: September 30, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Itraconazole
Hydroxyitraconazole
Docetaxel
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 21, 2014