Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

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Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT03987555
Run by: Wake Forest University Health Sciences
People needed: 22
Starts: 2019-11-11
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female sex
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
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

You may not qualify if…

Prior treatment with PTX, for any duration or indication
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 PTX (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)

Where it is running

Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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