Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

November 2, 2023 updated by: Wake Forest University Health Sciences

Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

The goals of this prospective, observational cohort study are to determine the feasibility of implementing paclitaxel therapeutic drug monitoring for cancer patients and explore the relationship between paclitaxel drug exposure and the development of neuropathic symptoms.

This trial studies if paclitaxel can be consistently measured in the blood of patients with solid tumors undergoing paclitaxel treatment. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nerve damage is one of the most common and severe side effects of paclitaxel. The ability to consistently measure paclitaxel in the blood may allow doctors to control the dose of paclitaxel, so that enough chemotherapy is given to kill the cancer, but the side effect of nerve damage is reduced.

Study Overview

Detailed Description

Primary Objective:

• Determine the feasibility of monitoring paclitaxel serum drug levels in patients with a solid tumor (e.g. lung, breast, and gynecologic cancers) for which Paclitaxel is the standard of care.

Secondary Objectives:

  • Compare Paclitaxel serum drug levels among patients with differing degrees of chemotherapy-induced peripheral neuropathy at the end of Paclitaxel treatment.
  • Compare mitochondrial function within circulating peripheral blood mononuclear cells among patients with differing degrees of chemotherapy-induced peripheral neuropathy at the end of Paclitaxel treatment.
  • Compare the ability of pulsed electromagnetic field to modulate immune cells of individuals experiencing differing degrees of chemotherapy-induced peripheral neuropathy at the end of Paclitaxel treatment.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
          • Ashley Fansler, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study is designed to enroll male and female patients with histologically-confirmed solid tumors who are anticipated to receive Paclitaxel as part of the curative or palliative antineoplastic therapy. The study will target lung, breast, and gynecologic (i.e. cervical, ovarian, uterine, and vulvar) cancers specifically.

Description

Inclusion Criteria:

  • Male or female sex
  • Age ≥ 18 years
  • Individuals receiving treatment at the Wake Forest Comprehensive Cancer Center who are anticipated to receive paclitaxel for curative or palliative intent, with or without surgery and/or radiation (i.e. neoadjuvant, adjuvant, or in the setting of recurrent or metastatic disease) as per decision with their medical oncologist for the following malignancies and dosing regimens:
  • Invasive breast cancer (any HER2 and ER/PR status)
  • Patients considered for curative or palliative chemotherapy with paclitaxel 80-175 mg/m2 with or without doxorubicin, cyclophosphamide, carboplatin, trastuzumab, bevacizumab, or pertuzumab

Cervical cancer • Patients considered for curative or palliative chemotherapy with paclitaxel 135-175 mg/m2 with or without cisplatin, carboplatin, topotecan, or bevacizumab

Non-small cell lung cancer

• Patients considered for curative or palliative chemotherapy with paclitaxel 45-200 mg/m2 with or without carboplatin, cisplatin, bevacizumab, atezolizumab, or pembrolizumab

Ovarian cancer • Patients considered for curative or palliative chemotherapy with paclitaxel 60-175 mg/m2 with or without carboplatin, cisplatin, ifosfamide, gemcitabine, pazopanib, or bevacizumab

Uterine neoplasms

• Patients considered for curative or palliative chemotherapy with paclitaxel 135-175 mg/m2 with or without carboplatin, cisplatin, doxorubicin, ifosfamide, bevacizumab, or trastuzumab

Vulvar cancer (squamous cell carcinoma)

  • Patients considered for curative or palliative chemotherapy with paclitaxel 60-175 mg/m2 with or without cisplatin, carboplatin, or bevacizumab
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)
  • Patients with prior radiation treatment or surgery will not be disqualified from enrollment into the study, unless the aforementioned interventions resulted in peripheral neuropathy as a complication

Exclusion Criteria:

  • Prior treatment with PTX, for any duration or indication
  • Prior treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum-containing agent, bortezomib, or thalidomide that has resulted in clinical symptoms of persistent, CTCAE grade II or higher peripheral neuropathy
  • Concurrent enrollment in a clinical study of a neuroprotective intervention at the time of study initiation
  • Any contraindication to Paclitaxel (e.g. history of allergic reaction to paclitaxel or Kolliphor EL)
  • Current signs or symptoms of peripheral neuropathy at the time of enrollment, e.g. due to diabetes, HIV, or other conditions
  • Known personal or family history of hereditary peripheral neuropathy (e.g. Charcot-Marie-Tooth disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Completing Paclitaxel Infusions
Time Frame: One day after last infusion dose
Feasibility will be assessed based on the proportion of patients who complete study blood draws at >90% of completed Paclitaxel infusions. A completed Paclitaxel infusion is defined as each dose of Paclitaxel that is completed in its entirety. The a priori success rate will be defined as 90% of patients receiving 100% of study blood draws and the null rate will be set at 50%
One day after last infusion dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Maximum Plasma Concentration of Paclitaxel from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
Differences in descriptive characteristics (e.g. mean, median, standard deviation, etc.) of the Paclitaxel maximum plasma concentration (Cmax) among patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE (Grade II or greater) at baseline and at the end of Paclitaxel treatment.
30 days after completion of chemotherapy treatment
Differences in Time Above Threshold from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
Differences in descriptive characteristics (e.g. mean, median, standard deviation, etc.) of time above threshold (Tc>0.05) among patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE (Grade II or greater) at baseline and at the end of Paclitaxel treatment.
30 days after completion of chemotherapy treatment
Differences in Inflammasome Activation from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
Differences in inflammasome activation following pulsed electromagnetic field stimulation between patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE at baseline and at the end of Paclitaxel treatment.
30 days after completion of chemotherapy treatment
Differences in Inflammatory Cytokine Production from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
Differences in inflammatory cytokine production following pulsed electromagnetic field stimulation between patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE at baseline and at the end of Paclitaxel treatment.
30 days after completion of chemotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roy Strowd, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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