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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Lung Cancer, Renal Cancer, Adrenal Cancer

Thank you

Trial Information

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


Background:

- Paclitaxel is a commonly used chemotherapeutic to which tumors can become resistant by
failing to accumulate sufficient concentrations of the agent to be lethal to the cell.

- A noninvasive imaging test could determine the uptake of paclitaxel by tumors

- The ability to non-invasively predict chemotherapeutic uptake in solid tumors could
help select patients likely to respond to treatment, estimate drug concentration within
the tumor and possibly aid in the development improved of drug delivery systems and
drug resistance evasion strategies.

- The PET department at the NIH developed an efficient procedure for fluorination of
paclitaxel to [18F]-labeled paclitaxel (FPAC) and studied its biodistribution in rats
and mice.

- Initial preclinical data shows the biodistribution of FPAC to be similar to that of
paclitaxel. It is proposed that the uptake kinetics of FPAC in vivo using PET imaging
will be representative of the uptake kinetics of paclitaxel

- First in human studies were performed by the PI (Kurdziel, KA) while at Virginia
Commonwealth University, Richmond VA in three normal volunteers and three breast cancer
patients with no adverse events. Human dosimetry estimates were obtained.

- PET/CT imaging with FPAC should permit quantitation of solid tumor uptake of the agent,
which in turn should parallel paclitaxel solid tumor kinetics.

- The physiological distribution of the agent limits its use below the diaphragm. Thus,
lung and breast cancers, which tend to be sensitive to taxanes, are the target tumors
in this study. Adrenal and renal tumors, which tend to be insensitive to taxanes are
being included as negative-control tumors.

Primary Objectives:

- Determine if the FPAC uptake in tumors is different than the uptake in normal
background tissues

- Determine safety of FPAC administration

Eligibility:

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

- Subjects must have histologically proven breast, adrenal, renal or lung cancer with a
lesion outside of the abdomen and pelvis greater than or equal to 1cm

- Subjects may not receive any other investigational agents 24 hours before or following
FPAC injection.

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

- Subjects must NOT be pregnant

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

Design:

In this protocol, we plan to stratify enrollment into 2 groups, enrolling 15 subjects in
each arm:

subjects with tumor type historically sensitive to paclitaxel therapy (lung and breast
cancers) and subjects with tumor generally not responsive to paclitaxel therapy (adrenal and
renal). Subjects will undergo regional dynamic FPAC PET/CT followed by static whole body
imaging. All participants will undergo FDG PET/CT (outside studies permitted if submitted in
DICOM format) Follow-up FDG PET/CT may be performed. (following at least 1 cycle of
therapy), if applicable. If the target lesion is surgically resected, the post-treatment
scan will not be performed. Subject is then expected to progress to standard or
investigational therapeutic intervention (not defined by this protocol). Data regarding
clinical and or imaging response to therapy will be collected if available. If a previous
biopsy specimen is available, IHC for known drug transporters will also be performed.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Principal Investigator

Karen A Kurdziel, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

100078

NCT ID:

NCT01086696

Start Date:

March 2010

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Renal Cancer
  • Adrenal Cancer
  • PET Imaging
  • F-18 Paclitaxel (FPAC)
  • Breast Cancer
  • Lung Cancer
  • Renal and Adrenal Cancers
  • Kidney Cancer
  • Adrenal Cancer
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms
  • Adrenal Gland Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892