- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987555
Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
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.
Study Overview
Status
Conditions
- Vulvar Cancer
- Recurrent Ovarian Carcinoma
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Prognostic Stage IV Breast Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Invasive Breast Cancer
- Malignant Uterine Neoplasm
- Recurrent Breast Carcinoma
- Recurrent Cervical Carcinoma
- Solid Tumor, Adult
- Metastatic Breast Carcinoma
- Stage IV Cervical Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IVB Cervical Cancer AJCC v8
- Stage IV Vulvar Cancer AJCC v8
- Stage IVA Vulvar Cancer AJCC v8
- Stage IVB Vulvar Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Recurrent Lung Non-Small Cell Carcinoma
- Metastatic Nonsmall Cell Lung Cancer
- Metastatic Ovarian Carcinoma
- Metastatic Cervical Carcinoma
- Recurrent Vulvar Carcinoma
- Vulva Squamous Cell Carcinoma
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ashley Fansler, RN
- Phone Number: 336-716-5440
- Email: arcarrol@wakehealth.edu
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Comprehensive Cancer Center
-
Contact:
- Ashley Fansler, RN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants Completing Paclitaxel Infusions
Time Frame: One day after last infusion dose
|
Feasibility will be assessed based on the proportion of patients who complete study blood draws at >90% of completed Paclitaxel infusions.
A completed Paclitaxel infusion is defined as each dose of Paclitaxel that is completed in its entirety.
The a priori success rate will be defined as 90% of patients receiving 100% of study blood draws and the null rate will be set at 50%
|
One day after last infusion dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Maximum Plasma Concentration of Paclitaxel from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
|
Differences in descriptive characteristics (e.g.
mean, median, standard deviation, etc.) of the Paclitaxel maximum plasma concentration (Cmax) among patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE (Grade II or greater) at baseline and at the end of Paclitaxel treatment.
|
30 days after completion of chemotherapy treatment
|
Differences in Time Above Threshold from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
|
Differences in descriptive characteristics (e.g.
mean, median, standard deviation, etc.) of time above threshold (Tc>0.05)
among patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE (Grade II or greater) at baseline and at the end of Paclitaxel treatment.
|
30 days after completion of chemotherapy treatment
|
Differences in Inflammasome Activation from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
|
Differences in inflammasome activation following pulsed electromagnetic field stimulation between patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE at baseline and at the end of Paclitaxel treatment.
|
30 days after completion of chemotherapy treatment
|
Differences in Inflammatory Cytokine Production from Baseline to Completion
Time Frame: 30 days after completion of chemotherapy treatment
|
Differences in inflammatory cytokine production following pulsed electromagnetic field stimulation between patients with and without chemotherapy-induced peripheral neuropathy according to the physician reported neuropathy CTCAE at baseline and at the end of Paclitaxel treatment.
|
30 days after completion of chemotherapy treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Roy Strowd, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Vulvar Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Breast Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Recurrence
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
- Uterine Neoplasms
Other Study ID Numbers
- IRB00058758
- P30CA012197 (U.S. NIH Grant/Contract)
- WFBCCC 01319 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
- NCI-2019-05616 (Other Identifier: National Cancer Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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