Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

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.

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
• Metastatic Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8
• Recurrent Breast Carcinoma
• Recurrent Cervical Carcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Vulvar Carcinoma
• Stage IV Cervical Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Vulvar Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IVA Cervical Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVA Ovarian Cancer AJCC v8
• Stage IVA Vulvar Cancer AJCC v8
• Stage IVB Cervical Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8
• Stage IVB Ovarian Cancer AJCC v8
• Stage IVB Vulvar Cancer AJCC v8
• Vulva Squamous Cell Carcinoma

Interventions

OTHER

Blood draws

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

OTHER

QLQ-CIPN20 Survey

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

OTHER

PR-CTCAE Survey

124-item survey addressing chemotherapy-induced peripheral neuropathy concerning severity of the numbness and tingling and the degree these symptoms interfere with daily activities.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Roy Strowd, MD · Wake Forest University Health Sciences

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-11

Primary Completion

2026-06-30

Completion

2026-07-31

Countries

• United States

Study Locations