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ACTIVE NOT RECRUITING
NCT04046094
PHASE1/PHASE2

Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.

Official title: IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2019-10-17

Completion Date

2026-08

Last Updated

2025-03-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ascorbic Acid

Ascorbic Acid Intravenous

Locations (3)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States