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.
Condition or disease | Intervention/treatment |
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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 | Other: Blood draws Other: QLQ-CIPN20 Survey Other: PR-CTCAE Survey |
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:
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients |
Actual Study Start Date : | November 11, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | August 2021 |
Tracking Information | |||||
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First Submitted Date | June 13, 2019 | ||||
First Posted Date | June 17, 2019 | ||||
Last Update Posted Date | March 30, 2021 | ||||
Actual Study Start Date | November 11, 2019 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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%
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Paclitaxel Therapeutic Drug Monitoring in Cancer Patients | ||||
Official Title | Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients | ||||
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. |
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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:
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
Blood draw for peripheral blood mononuclear cell isolation and subsequent use in pharmacogenomic assays.
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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. | ||||
Condition |
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Intervention |
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
20 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | August 2021 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
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)
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03987555 | ||||
Other Study ID Numbers | IRB00058758 WFBCCC 01319 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center ) P30CA012197 ( U.S. NIH Grant/Contract ) NCI-2019-05616 ( Other Identifier: National Cancer Institute ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Wake Forest University Health Sciences | ||||
Study Sponsor | Wake Forest University Health Sciences | ||||
Collaborators | National Cancer Institute (NCI) | ||||
Investigators |
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PRS Account | Wake Forest University Health Sciences | ||||
Verification Date | March 2021 |