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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 October 2012
• Main ID: NCT01086696
• Date of registration: 12/03/2010
• Primary sponsor: National Cancer Institute (NCI)
• Public title: A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers
• Scientific title: A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers
• Date of first enrolment: March 2010
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01086696
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

• Name: Yolanda McKinney, R.N.

• Name: Karen A Kurdziel, M.D.
• Affiliation: National Institutes of Health Clinical Center (CC)

Key inclusion & exclusion criteria

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Adrenal Cancer

Breast Cancer

Lung Cancer

Renal Cancer

Intervention(s)

Drug: F-18 Paclitaxel (FPAC)

Primary Outcome(s)

Determine if the FPAC uptake in tumors is different than the uptake in normal background tissues; Determine safety of FPAC administration

Secondary Outcome(s)

Compare FPAC uptake with FDG uptake in solid tumors; make preliminary comparisons of FPAC uptake with treatment response and drug transporter expression when available

Secondary ID(s)

10-C-0078

100078

Source(s) of Monetary Support

Please refer to primary and secondary sponsors