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Breast CancerEarly Phase 1NCT00572598

Pilot Study of 18F Fluoropaclitaxel (FPAC)

A Early Phase 1 study testing 4- [F-18] fluoropaclitaxel in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
4- [F-18] fluoropaclitaxel
Type of treatment
Injection or infusion
How many people
6 participants
Where
1 siteUnited States
Study dates
May 2005to Mar 2008
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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

Who cannot join

  • 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
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  • 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
  • •as above

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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

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.

Read the detailed description

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
Conditions
Breast Cancer
Being tested
4- [F-18] fluoropaclitaxel
Keywords
PET, multidrug resistance, fluoropaclitaxel, paclitaxel, breast cancer, dosimetry, imaging feasibility
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4- [F-18] fluoropaclitaxelDrug

    Also called FPAC

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging feasibility and dosimetry

    Measured: <6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2007 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572598
Sponsor's protocol ID
HM03748
Status last verified
Jan 2012
First submitted
11 Dec 2007
Last updated
12 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17161952

  • 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.

    PubMed 17921033

  • 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.

    PubMed 21849404

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 4- [F-18] fluoropaclitaxel in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging feasibility and dosimetry (time frame: <6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00572598, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.

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