Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 13, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how to better monitor the drug paclitaxel in patients with certain types of cancer, including breast, lung, cervical, ovarian, and vulvar cancers. Paclitaxel is a chemotherapy medication that helps stop cancer cells from growing, but it can also cause nerve damage, which is a common and serious side effect. By measuring the levels of paclitaxel in the blood, doctors hope to find ways to give enough medication to fight the cancer while reducing the chance of nerve damage.

To join this trial, participants must be at least 18 years old and receiving paclitaxel treatment at the Wake Forest Comprehensive Cancer Center for their cancer. This includes patients with various stages of breast cancer, lung cancer, cervical cancer, ovarian cancer, and vulvar cancer. Participants will be monitored throughout their treatment, and the information gathered will help improve how paclitaxel is used in the future. It's important for potential participants to understand the study details and to provide informed consent before joining.

Gender

ALL

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)