Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

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Brief Title

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Official Title

Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Brief 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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Proportion of Participants Completing Paclitaxel Infusions

Secondary Outcome

 Differences in Maximum Plasma Concentration of Paclitaxel from Baseline to Completion

Condition

Solid Tumor, Adult

Intervention

Blood draws


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

November 11, 2019

Completion Date

August 2021

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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 (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 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 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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Roy Strowd, MD, 336-716-5440, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03987555

Organization ID

IRB00058758

Secondary IDs

WFBCCC 01319

Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Roy Strowd, MD, Principal Investigator, Wake Forest University Health Sciences


Verification Date

March 2021