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Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03987555
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Solid Tumor, Adult Nonsmall Cell Lung Cancer Breast Cancer Cervical Cancer Ovarian Cancer Uterine Neoplasm Vulvar Cancer Other: Blood draws Other: QLQ-CIPN20 Survey Other: PR-CTCAE Survey

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021



Intervention Details:
  • Other: Blood draws
    Blood draws for serum and peripheral blood mononuclear cell isolation collected throughout treatment course
  • Other: QLQ-CIPN20 Survey
    20-item self-reported survey for participant reported symptoms related to chemotherapy-induced peripheral neuropathy
  • Other: PR-CTCAE Survey
    124-item survey addressing chemotherapy-induced peripheral neuropathy concerning severity of the numbness and tingling and the degree these symptoms interfere with daily activities.


Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Blood draw for peripheral blood mononuclear cell isolation and subsequent use in pharmacogenomic assays.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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 as a first line agent, 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 first line 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 first line 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 first line curative or palliative chemotherapy with paclitaxel 45-200 mg/m2 with or without carboplatin, cisplatin, bevacizumab, atezolizumab, or pembrolizumab

Ovarian cancer • Patients considered for first line 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 first line 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 first line 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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987555


Contacts
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Contact: Ashley Fansler, RN 336-716-5440 arcarrol@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashley Fansler, RN         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03987555     History of Changes
Other Study ID Numbers: IRB00058758
WFBCCC 01319 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Any stage solid tumor
Chemotherapy-induced peripheral neuropathy

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Vulvar Neoplasms
Carcinoma, Non-Small-Cell Lung
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action