A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00798135
First received: November 24, 2008
Last updated: August 7, 2013
Last verified: August 2012
  Purpose

Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too.

The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.


Condition Intervention
Breast Neoplasms
Neoplasm Metastasis
Drug: itraconazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring trough plasma levels at steady state and to correlate measures of angiogenesis with plasma levels of itraconazole and its active metabolite hydroxyitraconazole. [ Time Frame: Baseline through week 4 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2008
Estimated Study Completion Date: February 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: itraconazole
Patients will receive oral itraconazole 200mg a day until disease progression.
Drug: itraconazole
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

  Eligibility

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

Inclusion Criteria:

- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade <1 from all acute toxicity of previous therapy for breast cancer with the exception of alopecia. - Adequate hematologic and hepatic function: 1)Absolute neutrophil count >= 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin <= 1.5mg/dL x ULN 4) AST and/or ALT <= 2 x ULN (< 5 x ULN in presence of known liver metastasis). - Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and must practice an effective method of birth control. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should also practice an effective method of birth control. - All WOCBP MUST have a negative serum or urine pregnancy test within 4 weeks prior to the start of study drug administration.

Exclusion Criteria:

  • Use of the following concomitant medications within 14 days of starting protocol therapy is prohibited: Cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam, pimozide, quinidine, simvastatin, or triazolam.
  • Patients who are taking alprazolam (Xanax) are excluded from the trial.
  • Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics is allowed.
  • Hypersensitivity to itraconazole, any component of the formulation, or to other azoles.
  • Patients with uncontrolled CNS metastasis are excluded. If patients have CNS metastasis they must have completed brain radiation at least 2 weeks prior to registration and must be off steroids for CNS metastasis.
  • Known preexisting congestive heart failure or left ventricular dysfunction. Patients with risk factors (ex. uncontrolled hypertension with BP >160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798135

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00798135     History of Changes
Other Study ID Numbers: 0809-10; IUCRO-0239
Study First Received: November 24, 2008
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014