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

NCT ID: NCT00798135

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-03-31

Brief Summary

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.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

itraconazole

Patients will receive oral itraconazole 200mg a day until disease progression.

Group Type: EXPERIMENTAL

itraconazole

Intervention Type: DRUG

oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Interventions

itraconazole

oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kathy Miller

Ballvé-Lantero Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathy Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Melvin and Bren Simon Cancer Center

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0809-10; IUCRO-0239

Identifier Type: -

Identifier Source: org_study_id