Actively Recruiting
Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Led by University of Kansas Medical Center · Updated on 2025-02-20
48
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and willing to sign informed consent
- Consent to participate in the biorepository protocol approved by KU IRB
- Male or female aged 18 years or older
- ECOG Performance Status between 0 and 2
- Women of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Diagnosed with muscle invasive bladder cancer and either ineligible for or declined cisplatin chemotherapy based on specific clinical criteria
- Adequate organ function including certain blood counts, kidney and liver function, and normal G6PD status
- Agreement to use contraception or abstinence during the study and for a specified period after treatment end for men and women
You will not qualify if you...
- Currently enrolled in another therapeutic clinical trial
- Using or expecting to use other anti-cancer or investigational drugs during the study
- Having psychiatric illness or social situations limiting compliance
- Pregnant or breastfeeding
- Planning to conceive children during treatment and for 6 months (women) or 3 months (men) after treatment
- Known severe allergy to any component of the study drugs
- Active severe infection within 2 weeks before starting treatment
- Uncontrolled illnesses such as serious heart, lung, or gastrointestinal conditions
- Histology showing pure adenocarcinoma, squamous cell carcinoma, or small cell carcinoma
- Current use of tobacco products or tobacco use suspected during the trial
- History of G6PD deficiency
- History of kidney stones related to oxalate, unless deemed safe by physician
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Holden Comprehensive Cancer Center - The University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
2
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
K
KUCC Navigation
CONTACT
F
Faith Rahman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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