University of Kansas Medical Center
This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.
The investigator has hypothesized adding IVC to carbo/gem NAC will enhance pathological downstaging and improve QOL. The patients eligible for this study (cisplatin ineligible or declined with MIBC) typically proceed straight to cystectomy within 12 weeks of initial diagnosis. In this study, participants will receive two cycles of gemcitabine/carboplatin, along with IVC and then proceed to cystectomy.
Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent * Consent to participate in biorepository protocol number GUB-BCR-001, KU IRB Approved HSC # STUDY00141546 * Males and females age ≥ 18 years * ECOG Performance Status (PS) 0 - 2 * Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment. * Diagnosis/disease status Cisplatin-ineligible or declined muscle invasive bladder cancer. Cisplatin ineligibility will be defined based on Galsky criteria: CTCAE ver. 5…
A dose escalation regimen will be initiated for each participant at a single dose of 25 g, titrated to up target peak plasma concentration. Once established, IVC will be administered intravenously 2 times per week for the remaining cycles
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