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.
Additional locations may be listed on ClinicalTrials.gov for NCT03987555.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Roy Ervin Strowd
Phone: 336-716-7548
PRIMARY OBJECTIVE:
I. 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 (PTX) is the standard of care at Wake Forest Baptist Comprehensive Cancer Center (WFBCCC).
SECONDARY OBJECTIVES:
I. Compare PTX serum drug levels among patients with differing degrees of chemotherapy-induced peripheral neuropathy (CIPN) at the end of PTX treatment.
II. Compare mitochondrial function within circulating peripheral blood mononuclear cells among patients with differing degrees of CIPN at the end of PTX treatment.
III. Compare the ability of pulsed electromagnetic field (PEMF) to modulate immune cells of individuals experiencing differing degrees of CIPN at the end of PTX treatment.
EXPLORATORY OBJECTIVE:
I. Explore the relationship between PTX exposure and mitochondrial damage, immune system activation, and pharmacogenomic genotype.
OUTLINE:
Patients undergo blood collection 10 minutes before the end of every paclitaxel infusion, and 16-30 hours after paclitaxel infusion at cycle 1 dose 1 and halfway through the treatment course (cycle 3 for a 6 cycle regimen, cycle 6 for a 12 cycle regimen). Patients also complete surveys (10 minutes to complete) before chemotherapy, on last day of chemotherapy and 1 month after chemotherapy.
After completion of study, patients are followed up at 30 days.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRoy Ervin Strowd