NCT03987555

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-11
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2019-06-17
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States