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

Stopped early · Early Phase 1

Conditions studied: Breast Cancer, Lung Cancer, Renal Cancer, Adrenal Cancer

In brief

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.

Key facts

Study ID: NCT01086696
Run by: National Cancer Institute (NCI)
People needed: 6
Starts: 2010-03-09
Expected to finish: 2016-05-11
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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