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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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
Holden Comprehensive Cancer Center - The University of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGThe University of Kansas Cancer Center
Kansas City, Kansas, United States
RECRUITINGPost treatment pathological staging
To assess pathologic downstaging rate in MIBC cisplatin-ineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen. Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines.
Time frame: Approximately 10 to 12 weeks
To assess Quality of life (QOL)
Overall change in participant-reported quality of life outcomes. Fact-Bladder (FACT-BI) Quality of life questionnaire as measurement tool.
Time frame: Approximately 10 to 16 weeks
To measure Disease Free Survival (DFS)
Disease free survival rate (DFS) among participants
Time frame: Approximately 2 years
To measure Disease Specific Survival (DSS)
Disease specific survival rate among participants
Time frame: Approximately 2 years
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