Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Last updated: March 17, 2026
Sponsor: Wake Forest University Health Sciences
Overall Status: Suspended

Phase

N/A

Condition

Genitourinary Cancer

Vulvar Dysplasia And Carcinoma

Ovarian Cysts

Treatment

PR-CTCAE Survey

Blood draws

QLQ-CIPN20 Survey

Clinical Study ID

NCT03987555
IRB00058758
NCI-2019-05616
WFBCCC 01319
P30CA012197
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female sex

  • Age ≥ 18 years

  • Individuals receiving treatment at the Wake Forest Comprehensive Cancer Center whoare anticipated to receive paclitaxel for curative or palliative intent, with orwithout surgery and/or radiation (i.e. neoadjuvant, adjuvant, or in the setting ofrecurrent or metastatic disease) as per decision with their medical oncologist forthe following malignancies and dosing regimens:

  • Invasive breast cancer (any HER2 and ER/PR status)

  • Patients considered for curative or palliative chemotherapy with paclitaxel 80-175mg/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 60-175mg/m2 with or without cisplatin, carboplatin, or bevacizumab

  • Ability to understand and the willingness to sign an IRB-approved informed consentdocument

  • Patients with prior radiation treatment or surgery will not be disqualified fromenrollment into the study, unless the aforementioned interventions resulted inperipheral neuropathy as a complication

Exclusion

Exclusion Criteria:

  • 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 clinicalsymptoms of persistent, CTCAE grade II or higher peripheral neuropathy

  • Concurrent enrollment in a clinical study of a neuroprotective intervention at thetime of study initiation

  • Any contraindication to PTX (e.g. history of allergic reaction to paclitaxel orKolliphor 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)

Study Design

Total Participants: 22
Treatment Group(s): 3
Primary Treatment: PR-CTCAE Survey
Phase:
Study Start date:
November 11, 2019
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

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