Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Anatomic Stage IV Breast Cancer AJCC v8
Breast Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Ovarian Epithelial
Invasive Breast Cancer
Lung Neoplasms
Malignant Uterine Neoplasm
Metastatic Breast Carcinoma
Metastatic Cervical Carcinoma
Metastatic Nonsmall Cell Lung Cancer
Metastatic Ovarian Carcinoma
Ovarian Neoplasms
Prognostic Stage IV Breast Cancer AJCC v8
Recurrence
Recurrent Breast Carcinoma
Recurrent Cervical Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Vulvar Carcinoma
Solid Tumor, Adult
Stage IV Cervical Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Vulvar 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
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulva Squamous Cell Carcinoma
Vulvar Cancer
Vulvar Neoplasms

Clinical Trial Details

NCT number	NCT03987555
Study type	Observational
Source	Wake Forest University Health Sciences
Contact	Ashley Fansler, RN
Phone	336-716-5440
Email	arcarrol@wakehealth.edu
Status	Recruiting
Phase
Start date	November 11, 2019
Completion date	February 2025

View Details

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