Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Sponsors

Lead Sponsor: Wake Forest University Health Sciences

Collaborator: National Cancer Institute (NCI)

Source Wake Forest University Health Sciences
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.

Overall Status Recruiting
Start Date 2019-11-11
Completion Date 2022-04-01
Primary Completion Date 2021-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Proportion of Participants Completing Paclitaxel Infusions One day after last infusion dose
Secondary Outcome
Measure Time Frame
Differences in Maximum Plasma Concentration of Paclitaxel from Baseline to Completion 30 days after completion of chemotherapy treatment
Differences in Time Above Threshold from Baseline to Completion 30 days after completion of chemotherapy treatment
Differences in Inflammasome Activation from Baseline to Completion 30 days after completion of chemotherapy treatment
Differences in Inflammatory Cytokine Production from Baseline to Completion 30 days after completion of chemotherapy treatment
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Blood draws

Description: Blood draws for serum and peripheral blood mononuclear cell isolation collected throughout treatment course

Intervention Type: Other

Intervention Name: QLQ-CIPN20 Survey

Description: 20-item self-reported survey for participant reported symptoms related to chemotherapy-induced peripheral neuropathy

Intervention Type: Other

Intervention Name: PR-CTCAE Survey

Description: 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

Sampling Method:

Probability Sample

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

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Roy Strowd, MD Principal Investigator Wake Forest University Health Sciences
Overall Contact

Last Name: Ashley Fansler, RN

Phone: 336-716-5440

Email: [email protected]

Location
Facility: Status: Contact: Wake Forest Baptist Comprehensive Cancer Center Ashley Fansler, RN
Location Countries

United States

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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