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

NCT01086696 | Terminated Early Phase 1

• 2 other identifiers: 10007810-C-0078
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Lung Cancer; Renal Cancer; Adrenal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Uptake of FPAC in tumors

  1 hour post injection of FPAC

• Safety of FPAC

  1-3 days after FPAC injection

Study Arms (2)

1

EXPERIMENTAL

subjects with tumor types typically treatedwith taxanes

Drug: FPAC

2

EXPERIMENTAL

subjects with tumor types typically treatedwith taxanes

Drug: FPAC

Interventions

FPAC DRUG

Each subject will be administered 7 mCi of FPAC,over 10-20 seconds, followed by saline flush.

1; 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 17138742 BACKGROUND

• Logan J. Graphical analysis of PET data applied to reversible and irreversible tracers. Nucl Med Biol. 2000 Oct;27(7):661-70. doi: 10.1016/s0969-8051(00)00137-2.

  PMID: 11091109 BACKGROUND

• Tang HZ. [The changes of monoamine metabolites in CSF of patients with cerebral stroke]. Zhonghua Shen Jing Jing Shen Ke Za Zhi. 1991 Jun;24(3):130-2, 186. Chinese.

  PMID: 1716195 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Kidney Neoplasms; Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Karen A Kurdziel, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: March 9, 2010
• Primary Completion: August 20, 2014
• Study Completion: May 11, 2016
• Last Updated: December 17, 2019

Record last verified: 2016-05-11

Locations

US (1)