Monitoring paclitaxel levels in cancer patients
Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Wake Forest University Health Sciences · NCT03987555
This study is testing if checking the levels of the cancer drug paclitaxel in the blood can help doctors better manage treatment and reduce nerve damage in cancer patients with solid tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Drugs / interventions | trastuzumab, bevacizumab, pertuzumab, atezolizumab, pembrolizumab, chemotherapy, radiation, cyclophosphamide, doxorubicin |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03987555 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the feasibility of monitoring paclitaxel drug levels in the blood of cancer patients with solid tumors. It will explore the relationship between paclitaxel exposure and the development of neuropathic symptoms, a common side effect of the drug. The study will involve blood draws and surveys to evaluate chemotherapy-induced peripheral neuropathy and mitochondrial function. By measuring drug levels, the goal is to optimize paclitaxel dosing to effectively treat cancer while minimizing nerve damage.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older receiving paclitaxel treatment for solid tumors such as breast, lung, cervical, or ovarian cancers.
Not a fit: Patients not receiving paclitaxel or those with non-solid tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer chemotherapy regimens for cancer patients.
How similar studies have performed: While the specific approach of monitoring paclitaxel levels is novel, similar studies have shown the importance of drug monitoring in optimizing chemotherapy outcomes.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Roy Strowd, MD — Wake Forest University Health Sciences
- Study coordinator: Ashley Fansler, RN
- Email: arcarrol@wakehealth.edu
- Phone: 336-716-5440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: 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