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出境医 / 临床实验 / Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Study Description
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.

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.


Condition or disease Intervention/treatment
Solid Tumor, Adult Metastatic Nonsmall Cell Lung Cancer Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Cervical Carcinoma Metastatic Ovarian Carcinoma Malignant Uterine Neoplasm Vulvar Cancer Invasive Breast Cancer Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Recurrent Cervical Carcinoma Recurrent Lung Non-Small Cell Carcinoma Recurrent Ovarian Carcinoma Recurrent Vulvar Carcinoma Stage IV Cervical Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Vulvar Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IVA Cervical Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Vulvar Cancer AJCC v8 Stage IVB Cervical Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Vulvar Cancer AJCC v8 Vulva Squamous Cell Carcinoma 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.
Study Design
Layout table for study information
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
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Outcome Measures
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.

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 17, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date November 11, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2019)
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%
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Official Title Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
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.

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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood draw for peripheral blood mononuclear cell isolation and subsequent use in pharmacogenomic assays.
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.
Condition
  • Solid Tumor, Adult
  • Metastatic Nonsmall Cell Lung Cancer
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Cervical Carcinoma
  • Metastatic Ovarian Carcinoma
  • Malignant Uterine Neoplasm
  • Vulvar Cancer
  • Invasive Breast Cancer
  • Metastatic Breast Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Recurrent Breast Carcinoma
  • Recurrent Cervical Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Vulvar Carcinoma
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Vulvar Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Cervical Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Vulvar Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Vulvar Cancer AJCC v8
  • Vulva Squamous Cell Carcinoma
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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, 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ashley Fansler, RN 336-716-5440 arcarrol@wakehealth.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03987555
Other Study ID Numbers IRB00058758
WFBCCC 01319 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
NCI-2019-05616 ( Other Identifier: National Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date March 2021

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