Breast Neoplasm Female
Conditions
Brief summary
The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.
Detailed description
Primary Objectives * To test if cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Secondary Objectives * To identify patient-specific differences in tumor levels and distribution of paclitaxel at 20 hours after first dose and patient-specific differences in peripheral non-tumor tissue (skin or plasma) paclitaxel levels 20 ± 4 hours after first dose. * To determine if paclitaxel levels are higher at 20h after the 3rd dose than after the first dose, and if levels are higher at 20h after the 10th, 11th, or 12th dose than the 1st and 3rd dose. * Compare pre-existing versus post-treatment antimitotic effects at 20h after the 1st dose, 20h after the 3rd dose, and 20h after the 10th, 11th, or 12th dose. * Correlate drug levels and distribution with biomarkers including mitotic index, aneuploidy, chromosomal instability, and Ki67. * Correlate pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, CIN and Ki67. * To test if CIN increases in patient tumors in response to paclitaxel and to evaluate the feasibility of these measurements by genomic analysis. Initial Actual Primary and Study Completion Date registered as 8/16/2022 with 24 participants enrolled. Per a Protocol Amendment dated 5/7/24, this study will re-open to enroll up to 50 participants. NCI funding and data sharing information added.
Interventions
DRUGPaclitaxel
Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
Sponsors
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with pathologically demonstrated breast cancer * Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel. * Patients must not have metastatic disease on staging work-up per institutional guidelines. * A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor (preferred) or lymph node. A minimum of 8 slides must be available. * The primary tumor or lymph node must be readily biopsied by surgery or radiology teams. * The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians. * Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted. * Patients must have adequate organ and marrow function as determined by the treating oncologist. * Patient must be willing to undergo additional biopsy of breast tumor or lymph node. * Patient must have the ability and willingness to sign a written informed consent document. * Women of childbearing potential (per institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.
Exclusion criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil). * Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications. * Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements as determined by treatment physician. * Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Paclitaxel | Up to 3 months | To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Level Difference of Paclitaxel | Up to 1 day | Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics. |
| Non-Tumor Level Difference of Paclitaxel | Up to 1 day | Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics. |
| Paclitaxel Levels | Up to 79 days | Paclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics. |
| Antimitotic Effects | Up to 79 days | Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis. |
| Mitotic Index | Baseline and 20 hours post-first dose | The mitotic index is a measure of cells arresting in mitosis, previously thought to be the major mechanism of taxol action. It is defined as the percentage of cells undergoing mitosis in a given population of cells. An elevated mitotic index indicates more cells are at this phase of the cell cycle at the time of sampling. |
| Correlate Drug Levels With Aneuploidy of Tumor | Up to 3 months | Correlate pathologic response and clinical response with biomarkers including aneuploidy |
| Correlate Drug Levels With Chromosomal Instability of Tumor | Up to 3 months | Correlate pathologic response and clinical response with biomarkers including CIN |
| Ki67 of Tumor | Up to 3 months | The Ki-67 protein is a cellular marker for proliferation. Ki-67 is an excellent marker to determine the growth fraction of a given cell population. The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer. |
| Change in CIN Levels | Baseline and 20 hours post-first dose | There are many proposed ways to measure CIN. Here, we used # of multipolar spindles as a surrogate of CIN measures. |
Countries
United States
Contacts
CONTACTCancer Connect
PRINCIPAL_INVESTIGATORMarina Sharifi, MD, PhD
University of Wisconsin, Madison
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weekly Paclitaxel Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Weekly Paclitaxel |
|---|---|
| Age, Customized 20-29 years | 1 Participants |
| Age, Customized 30-39 years | 4 Participants |
| Age, Customized 40-49 years | 7 Participants |
| Age, Customized 50-59 years | 7 Participants |
| Age, Customized 60-69 years | 2 Participants |
| Age, Customized 70-79 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Response to Paclitaxel
To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria
Time frame: Up to 3 months
Population: Only 12 participants were evaluable because of insufficient specimen.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weekly Paclitaxel | Response to Paclitaxel | -29.63 percent decrease in tumor size |
Secondary
Antimitotic Effects
Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis.
Time frame: Up to 79 days
Population: An increasing smaller subset of participants were biopsied after the first dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Antimitotic Effects | Participant 9 | 35 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 4 | 101 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 11 | 6 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 1 | 113 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 12 | 24 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 6 | 106 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 13 | 106 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 3 | 100 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 16 | 106 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 14 | 86 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 18 | 42 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 7 | 79 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 15 | 116 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 2 | 41 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 8 | 75 number of mitotic cells |
| Weekly Paclitaxel | Antimitotic Effects | Participant 19 | 30 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 19 | 70 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 1 | 109 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 2 | 100 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 3 | 104 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 4 | 103 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 6 | 108 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 7 | 103 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 8 | 27 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 9 | 63 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 11 | 11 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 12 | 30 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 13 | 110 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 14 | 102 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 15 | 101 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 16 | 104 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After First Dose | Antimitotic Effects | Participant 18 | 214 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Third Dose | Antimitotic Effects | Participant 3 | 105 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Third Dose | Antimitotic Effects | Participant 2 | 32 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Third Dose | Antimitotic Effects | Participant 18 | 23 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Third Dose | Antimitotic Effects | Participant 14 | 20 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Third Dose | Antimitotic Effects | Participant 13 | 101 number of mitotic cells |
| Weekly Paclitaxel - 20 Hours After Twelfth Dose | Antimitotic Effects | Participant 18 | 8 number of mitotic cells |
Secondary
Change in CIN Levels
There are many proposed ways to measure CIN. Here, we used # of multipolar spindles as a surrogate of CIN measures.
Time frame: Baseline and 20 hours post-first dose
Population: Insufficient tissue was collected to complete analysis on remaining participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Change in CIN Levels | Participant 1 | 7.08 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 9 | 8.571428571 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 6 | 16.98113208 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 11 | 0 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 2 | 2.44 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 12 | 4.2 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 7 | 3.797468354 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 13 | 5.6 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 4 | 3.96039604 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 14 | 13.95 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 8 | 5.33333333 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 15 | 3.45 % of cells with multipolar spindles |
| Weekly Paclitaxel | Change in CIN Levels | Participant 3 | 2.44 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 15 | 60.4 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 1 | 51.38 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 2 | 49 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 3 | 26.92 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 4 | 29.12621359 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 6 | 60.18518519 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 7 | 64.0776699 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 8 | 62.96296296 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 9 | 61.9047619 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 11 | 27.27 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 12 | 56.6 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 13 | 64.5 % of cells with multipolar spindles |
| Weekly Paclitaxel - 20 Hours After First Dose | Change in CIN Levels | Participant 14 | 58.82 % of cells with multipolar spindles |
Secondary
Correlate Drug Levels With Aneuploidy of Tumor
Correlate pathologic response and clinical response with biomarkers including aneuploidy
Time frame: Up to 3 months
Population: This biomarker was not measured
Secondary
Correlate Drug Levels With Chromosomal Instability of Tumor
Correlate pathologic response and clinical response with biomarkers including CIN
Time frame: Up to 3 months
Population: This was not measured
Secondary
Ki67 of Tumor
The Ki-67 protein is a cellular marker for proliferation. Ki-67 is an excellent marker to determine the growth fraction of a given cell population. The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer.
Time frame: Up to 3 months
Population: Clinical Response reported here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Ki67 of Tumor | Participant 1 | 90 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 2 | 80 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 3 | 90 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 6 | 45 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 7 | 90 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 8 | 60 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 9 | 15 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 11 | 20 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 12 | 25 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 13 | 90 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 14 | 60 Percentage of Ki67 + cells |
| Weekly Paclitaxel | Ki67 of Tumor | Participant 15 | 60 Percentage of Ki67 + cells |
Secondary
Mitotic Index
The mitotic index is a measure of cells arresting in mitosis, previously thought to be the major mechanism of taxol action. It is defined as the percentage of cells undergoing mitosis in a given population of cells. An elevated mitotic index indicates more cells are at this phase of the cell cycle at the time of sampling.
Time frame: Baseline and 20 hours post-first dose
Population: Clinical Response reported here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Mitotic Index | Participant 8 | 0.6 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 4 | 1.8 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 9 | 1.466667 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 11 | 0.198311 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 1 | 1.4 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 12 | 0.32 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 6 | 1.052765 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 13 | 2 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 3 | 1.35 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 14 | 1.48 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 7 | 1.2 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 15 | 1.33 mitotic index |
| Weekly Paclitaxel | Mitotic Index | Participant 2 | 1 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 15 | 5.56 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 1 | 2.6 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 2 | 3.379722 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 3 | 4.4 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 4 | 3.192745 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 6 | 2.305837 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 7 | 3.201638 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 8 | 1.29731 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 11 | 0.32 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 12 | 1.44 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 13 | 4.2 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 14 | 2.87 mitotic index |
| Weekly Paclitaxel - 20 Hours After First Dose | Mitotic Index | Participant 9 | 1.872558 mitotic index |
Secondary
Non-Tumor Level Difference of Paclitaxel
Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Time frame: Up to 1 day
Population: Participant 10 withdrew consent
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 1 | 0.023 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 2 | 0.040 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 3 | 0.030 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 4 | 0.027 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 5 | 0.031 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 6 | 0.020 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 7 | 0.013 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 8 | 0.011 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 9 | 0.020 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 11 | 0.038 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 12 | 0.040 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 13 | 0.094 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 14 | 0.048 micromolar |
| Weekly Paclitaxel | Non-Tumor Level Difference of Paclitaxel | Participant 15 | 0.035 micromolar |
Secondary
Paclitaxel Levels
Paclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics.
Time frame: Up to 79 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Weekly Paclitaxel | Paclitaxel Levels | First dose plasma paclitaxel | 0.041 micromolars |
| Weekly Paclitaxel | Paclitaxel Levels | Third dose plasma paclitaxel | 0.029 micromolars |
| Weekly Paclitaxel | Paclitaxel Levels | First dose intratumoral paclitaxel | 0.785 micromolars |
| Weekly Paclitaxel | Paclitaxel Levels | Third dose intratumoral paclitaxel | 1.21 micromolars |
Secondary
Tumor Level Difference of Paclitaxel
Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Time frame: Up to 1 day
Population: Participant 10 withdrew consent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 1 | 1.07 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 2 | 0.34 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 3 | 0.80 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 4 | 0.57 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 6 | 3.43 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 7 | 1.55 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 8 | 0.53 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 9 | 0.63 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 11 | 0.57 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 13 | 1.67 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 14 | 0.52 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 15 | 1.20 micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 5 | NA micromolar |
| Weekly Paclitaxel | Tumor Level Difference of Paclitaxel | Participant 12 | NA micromolar |