Finding studies
Finding studies
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Cancer Connect
CONTACT
Lead
University of Wisconsin, Madison
With
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
