Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-07 @ 1:30 PM
Study NCT ID:
NCT03096418
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2017-03-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-00338 | REGISTRY | NCI CTRP | View | |
| 2016-1489 | OTHER | Institutional Review Board | View | |
| A534260 | OTHER | UW Madison | View | |
| SMPH\MEDICINE\HEM-ONC | OTHER | UW Madison | View | |
| Protocol Version 6/12/2025 | OTHER | UW Madison | View | |
| 1R01CA284747-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |