Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    20
  • sponsor
    Wake Forest University Health Sciences
Updated on 28 June 2021
paclitaxel
cancer
cyclophosphamide
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
doxorubicin
metastasis
carboplatin
pertuzumab
tumor cells
gemcitabine
pembrolizumab
bevacizumab
trastuzumab
neuropathy
solid tumour
ovarian cancer
invasive breast cancer
ifosfamide
therapeutic drug monitoring
atezolizumab
topotecan
pazopanib

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.

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.

Details
Condition Uterine Cancer, Malignant neoplasm of vulva, Recurrent Cervical Cancer, Recurrent Ovarian Carcinoma, Recurrent Breast Cancer, Invasive Breast Cancer, Stage IV Ovarian Cancer, Recurrent Breast Carcinoma, Stage IV Non-small Cell Lung Cancer, Vulvar Carcinoma, Metastatic Non-small Cell Lung Cancer, Recurrent Cervical Carcinoma, Recurrent Vulvar Carcinoma, Recurrent Ovarian Cancer, Metastatic Breast Carcinoma, Metastatic Nonsmall Cell Lung Cancer, Stage IV Ovarian Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Metastatic NSCLC, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IV Vulvar Cancer AJCC v8, Stage IVA Vulvar Cancer AJCC v8, Stage IVB Vulvar Cancer AJCC v8, Stage IV Ovarian Carcinoma, Metastatic Cervical Carcinoma, Stage IV NSCLC, Solid Tumor, Adult, Metastatic Ovarian Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Vulva Squamous Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, vulvar cancer, vulva cancer, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma, Solid Tumor, Adult, Recurrent Lung Non-Small Cell Carcinoma
Treatment Blood draws, QLQ-CIPN20 Survey, PR-CTCAE Survey
Clinical Study IdentifierNCT03987555
SponsorWake Forest University Health Sciences
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

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
-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
-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)
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