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SUSPENDED
NCT03987555

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Official title: Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

22

Start Date

2019-11-11

Completion Date

2026-12

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States