NIH Clinical Center logo     America's Clinical Research Hospital File folder iconExplore the NIH
Clinical Center
Search the Studies - NIH Clinical Research Studies

Protocol Details

A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-C-0078

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

PET Imaging;
F-18 Paclitaxel (FPAC);
Breast Cancer;
Lung Cancer;
Renal and Adrenal Cancers

Recruitment Keyword(s)

Breast Cancer;
Lung Cancer;
Kidney Cancer;
Adrenal Cancer

Condition(s)

Breast Cancer;
Lung Cancer;
Renal Cancer;
Adrenal Cancer

Investigational Drug(s)

FPAC (F-18 Paclitaxel)

Investigational Device(s)

None

Intervention(s)

Drug: F-18 Paclitaxel (FPAC)

Supporting Site

National Cancer Institute

Background:

- Paclitaxel is a chemotherapy drug that is commonly used to treat different types of cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer cells. Researchers are interested in studying whether tumors have become resistant to paclitaxel, but to do so it must be possible to see how much paclitaxel is absorbed by the tumor cells.

- 18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be slightly radioactive in order to show up on positron emission tomography (PET) scans. By injecting a very small amount (much less that that used to treat tumors) of the radiolabeled drug into the body, researchers hope to use PET scans to evaluate the amount of the drug absorbed by solid tumors. Because FPAC is best used to study tumors located above the diaphragm, all subjects in the study will have tumors near or above the diaphragm.

Objectives:

- To determine the safety and effectiveness of FPAC as a radiological evaluation chemical.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with breast, adrenal, renal, or lung cancer and have a tumor located someone in the body at least 1 centimeter above the diaphragm.

Design:

- Participants will be screened with a physical exam, blood tests, and imaging studies as directed by the study researchers.

- Participants will receive a single dose of FPAC, followed by a series of PET scans. Regular scans will be performed for 3 hours after the dose of FPAC.

- Participants will also have a single dose of a more conventional radiotracer, followed by a series of PET scans. The results of the two sets of scans will be compared with information from previous imaging studies of participants' tumors.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

- Subjects must have a history of histologically or cytologically confirmed breast, lung, adrenal or renal cancer with a tumor above the diaphragm greater than or equal to 1 cm

-Subjects must be 18 years or older for inclusion in this study.

- Subjects must sign a written informed consent document and in accordance with institutional guidelines.

-If female, the subject must be postmenopausal for a minimum of two years, be surgically sterile, or have a negative pregnancy test within the 24 hours prior to tracer injection

- There are no study related limitations regarding previous radiation or chemotherapy.

- Subjects must have an ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)

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

- leukocytes greater than or equal to 3,000/mcL

- absolute neutrophil count greater than or equal to 1,500/mcL

- platelets greater than or equal to 100,000/mcL

- total bilirubin within less than or equal to 2.5 times institutional limits OR < 3.0 mg/dl in patients with Gilbert s syndrome

- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 times the institutional upper limit of normal (< 5 times the ULN for patients with known hepatic metastases)

-When applicable, a documented history of prior chemotherapy and radiation therapy and responses to those treatments must be available.

EXCLUSION CRITERIA:

- Subjects may not receive any other investigational agents 24 hours prior to or following FPAC injection

- Subjects must NOT receive radiation therapy to the target lesion less than or equal to 8 weeks prior to FPAC injection

- Subjects must NOT have had surgery near the target lesion less than or equal to 4 weeks prior to FPAC injection

- Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluoropaclitaxel (i.e. Taxol)

- Subjects with severe claustrophobia (not relieved by oral anxiolytics) or other condition that would make them unable to lie still for the duration of the study

- Subjects with uncontrolled intercurrent illness 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.


--Back to Top--

Citations:

Hsueh WA, Kesner AL, Gangloff A, Pegram MD, Beryt M, Czernin J, Phelps ME, Silverman DH. Predicting chemotherapy response to paclitaxel with 18F-Fluoropaclitaxel and PET. J Nucl Med. 2006 Dec;47(12):1995-9.

Logan J. Graphical analysis of PET data applied to reversible and irreversible tracers. Nucl Med Biol. 2000 Oct;27(7):661-70.

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. Epub 2006 Dec 11.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Karen A. Kurdziel, M.D.
National Cancer Institute (NCI)
BG 10 RM B3B403
10 CENTER DR
BETHESDA MD 20814
(301) 443-0622
kurdziek@mail.nih.gov

Yolanda McKinney, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B3B81
10 Center Drive
Bethesda, Maryland 20892
(301) 443-6913
ymckinney@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01086696

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

  • Details on how to participate in a study
  • Details on how to refer a patient to a study

NIH Clinical Studies Information Request


Contact the Office of Communications for:

  • General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml


Contact the Department Clinical Research Informatics, (DCRI) for:

  • Technical questions about Adobe Acrobat and the PDF format
  • Technical questions about this web server

webmaster@cc.nih.gov