Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
NCT ID: NCT03987555
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2019-11-11
2026-07-31
Brief Summary
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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
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• 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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood draws
Blood draws for serum and peripheral blood mononuclear cell isolation collected throughout treatment course
QLQ-CIPN20 Survey
20-item self-reported survey for participant reported symptoms related to chemotherapy-induced peripheral neuropathy
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.
Eligibility Criteria
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Inclusion Criteria
* 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 45-200 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 135-175 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 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Roy Strowd, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Fansler, RN
Role: primary
Other Identifiers
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WFBCCC 01319
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2019-05616
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00058758
Identifier Type: -
Identifier Source: org_study_id