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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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

    Detailed Summary:

    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 inclu
      Sponsor: National Cancer Institute (NCI)

      Current Primary Outcome:

      • Uptake of FPAC in tumors [ Time Frame: 1 hour post injection of FPAC ]
      • Safety of FPAC [ Time Frame: 1-3 days after FPAC injection ]


      Original Primary Outcome: -Determine if the FPAC uptake in tumors is different than the uptake in normal background tissues-Determine safety of FPAC administration

      Current Secondary Outcome:

      Original Secondary Outcome: -Compare FPAC uptake with FDG uptake in solid tumors-Make preliminary comparisons of FPAC uptake with treatment response and drug transporter expression when available

      Information By: National Institutes of Health Clinical Center (CC)

      Dates:
      Date Received: March 12, 2010
      Date Started: March 9, 2010
      Date Completion:
      Last Updated: May 12, 2017
      Last Verified: May 11, 2016