Pilot Study of 18F Fluoropaclitaxel (FPAC)

NCT00572598 | Completed Early Phase 1

• 1 other identifier: HM03748
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR refers to a phenotype whereby a tumor is resistant to a large number of natural chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would decrease morbidity from unsuccessful therapy and allow for the selection of individuals who may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However, positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the promise of more accurate and specific identification of MDR tumors. Objective: To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with response to therapy.

Conditions

Breast Cancer

Keywords

PET; multidrug resistance; fluoropaclitaxel; paclitaxel; breast cancer; dosimetry; imaging feasibility

Outcome Measures

Primary Outcomes (1)

• Imaging feasibility and dosimetry

  <6months

Interventions

4- [F-18] fluoropaclitaxel DRUG

4- \[F-18\] fluoropaclitaxel, \<84 micrograms, \<10 mCi, IV followed by PET/CT imaging

Also known as: FPAC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• Kalen JD, Hirsch JI, Kurdziel KA, Eckelman WC, Kiesewetter DO. Automated synthesis of 18F analogue of paclitaxel (PAC): [18F]Paclitaxel (FPAC). Appl Radiat Isot. 2007 Jun;65(6):696-700. doi: 10.1016/j.apradiso.2006.10.015. Epub 2006 Dec 11.

  PMID: 17161952 BACKGROUND

• Kurdziel KA, Kalen JD, Hirsch JI, Wilson JD, Agarwal R, Barrett D, Bear HD, McCumiskey JF. Imaging multidrug resistance with 4-[18F]fluoropaclitaxel. Nucl Med Biol. 2007 Oct;34(7):823-31. doi: 10.1016/j.nucmedbio.2007.04.011. Epub 2007 Jul 5.

  PMID: 17921033 RESULT

• Kurdziel KA, Kalen JD, Hirsch JI, Wilson JD, Bear HD, Logan J, McCumisky J, Moorman-Sykes K, Adler S, Choyke PL. Human dosimetry and preliminary tumor distribution of 18F-fluoropaclitaxel in healthy volunteers and newly diagnosed breast cancer patients using PET/CT. J Nucl Med. 2011 Sep;52(9):1339-45. doi: 10.2967/jnumed.111.091587. Epub 2011 Aug 17.

  PMID: 21849404 RESULT

Related Links

• VCU Molecular Imaging Center Home Page

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Harry D. Bear, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

US (1)