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Pilot Study of 18F Fluoropaclitaxel (FPAC) in Breast Cancer Patients and Normal Volunteers: Dosimetry and Imaging Feasibility


Phase 0
18 Years
90 Years
Not Enrolling
Both
Breast Cancer

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Trial Information

Pilot Study of 18F Fluoropaclitaxel (FPAC) in Breast Cancer Patients and Normal Volunteers: Dosimetry and Imaging Feasibility


18F flouropaclitaxel (FPAC) distribution in malignant tumors is expected to be similar to
that of paclitaxel. It is proposed that by monitoring the influx and efflux of FPAC in vivo
using PET imaging, we will be able to determine if a tumor retains the drug (is drug
sensitive) or pumps it out (is drug resistant). The efflux rate of FPAC in the tumor should
be proportional the amount of Pgp present and therefore should be a predictor of treatment
failure. If this method is successful at identifying MDR, patients can be spared a course
of ineffective chemotherapy and can be started on alternative drugs or, if available, an
effective MDR modulator can be administered prior to treatment.

In order to validate the biodistribution in non-human primate, 3 normal volunteers will be
recruited to participate in a dosimetry PET imaging protocol.

Often, patients with breast cancer are treated with chemotherapy prior to definitive
surgical removal of the primary tumor. Three patients with breast cancer who are candidates
for this neoadjuvant chemotherapy will also be recruited to participate in this study, in
order to demonstrate the feasibility of tumor imaging. As these patients will be receiving
chemotherapy (likely paclitaxel), a preliminary correlation with FPAC uptake and tumor
response can also be attempted in this pilot study.

Primary Objective

--To obtain human dosimetry and monitor for potential physiologic effects following 4-[F-18]
fluoropaclitaxel (FPAC) administration

Secondary Objectives

- a.To characterize tracer uptake in tumors and normal tissues and develop robust methods
for analysis of FPAC kinetics in breast tumors

- b.To optimize the imaging protocol for FPAC, and, if feasible, reduce to 1 or 2 static
scans


Normal Volunteers

Inclusion Criteria:



- Subjects must be 18 years or older for inclusion in this study. Because no dosing or
adverse event data are currently available on the use of FPAC in patients <18 years
of age, children are excluded from this study but will be eligible for future
pediatric single-agent trials, if applicable.

- All subjects must sign a written informed consent document and a Health
Insurance Portability and Accountability Act (HIPAA) authorization in accordance
with institutional guidelines.

- If female, the subject must be postmenopausal for a minimum of one year, or
surgically sterile, or be within 14 days of onset of a menstrual period or have
a negative beta human chorionic gonadotropin (ßHCG) blood test.

- Subjects must have normal organ and marrow function as defined below:

- Leukocytes >3,000/μL

- absolute neutrophil count >1,500/μL

- platelets >100,000/μL

- total bilirubin within normal institutional limits

- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the
institutional upper limit of normal

- Creatinine within normal institutional limits OR, in subjects with creatinine
levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2

Exclusion Criteria:

- Subject with a known bleeding disorder

- Subjects who have received chemotherapy within 1 year of entry into study

- Subjects with a history of liver or kidney disease

- Subjects who are receiving any other investigational agents

- Subjects having severe claustrophobia or other condition that would make them
unable to lie still for the duration of the study

- Subjects with immunodeficiencies that predispose a subject to specific or
non-specific mediator release

- Subjects with uncontrolled intercurrent illness, including but not limited to
ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements

- Subjects who are pregnant or lactating or who suspect they might be pregnant.
Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with FPAC, breastfeeding should be
discontinued if the mother receives FPAC.

Breast Cancer Patients

Inclusion Criteria:



- Subjects must have a history of histologically or cytologically confirmed breast
cancer with estimated lesion size of >1cm.

- Subjects must be 18 years or older for inclusion in this study. Because no
dosing or adverse event data are currently available on the use of FPAC in
patients <18 years of age, children are excluded from this study but will be
eligible for future pediatric single-agent trials, if applicable.

- All subjects must sign a written informed consent document and a HIPAA
authorization in accordance with institutional guidelines.

- If female, the subject must be postmenopausal for a minimum of one year, be
surgically sterile, be within 14 days of onset of a menstrual period, or have a
negative ßHCG blood test.

- Subjects must have normal organ and marrow function as defined below:

- Leukocytes >3,000/μL

- absolute neutrophil count >1,500/μL

- platelets >100,000/μL

- total bilirubin within normal institutional limits

- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the
institutional upper limit of normal

- Creatinine within normal institutional limits OR, in subjects with creatinine
levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2

Exclusion Criteria:

•as above

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Imaging feasibility and dosimetry

Outcome Time Frame:

<6months

Safety Issue:

No

Principal Investigator

Harry D. Bear, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Food and Drug Administration

Study ID:

HM03748

NCT ID:

NCT00572598

Start Date:

May 2005

Completion Date:

March 2008

Related Keywords:

  • Breast Cancer
  • PET
  • multidrug resistance
  • fluoropaclitaxel
  • paclitaxel
  • breast cancer
  • dosimetry
  • imaging feasibility
  • Breast Neoplasms

Name

Location

Virginia Commonwealth UniversityRichmond, Virginia