Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

NCT03987555 | Suspended DMC

• 4 other identifiers: IRB00058758WFBCCC 01319P30CA012197NCI-2019-05616
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

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 IVB Lung Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8; Stage IVB Vulvar Cancer AJCC v8; Stage IVA Vulvar Cancer AJCC v8; Stage IVB Cervical Cancer AJCC v8; Vulva Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Completing Paclitaxel Infusions

  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 Outcomes (4)

• 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

Interventions

Blood draws OTHER

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

PR-CTCAE Survey OTHER

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

QLQ-CIPN20 Survey OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is designed to enroll male and female patients with histologically-confirmed solid tumors who are anticipated to receive Paclitaxel as part of the curative or palliative antineoplastic therapy. The study will target lung, breast, and gynecologic (i.e. cervical, ovarian, uterine, and vulvar) cancers specifically.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 PTX (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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw for peripheral blood mononuclear cell isolation and subsequent use in pharmacogenomic assays.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Vulvar Neoplasms; Breast Neoplasms; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Roy Strowd, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: November 11, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)