NCT04046094Active, not recruitingPhase 1/2
Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 2 Aug 2019
- Start date
- 17 Oct 2019
- Primary completion date
- 12 Sept 2022
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT04046094
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 12
- From 17 Oct 2019 to the primary completion date, 12 Sept 2022
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or anticipated use of other investigational agents while participating in this study
- Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
Other illness
- Psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled intercurrent illness
Lab values
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Other
- Patient simultaneously enrolled in any therapeutic clinical trial
- Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
- Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
- Current consumption of tobacco products
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
- Cisplatin-ineligible, muscle invasive bladder cancer
- Adequate organ and marrow functions
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Kansas Cancer Center (KUCC) Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| The University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Cancer Center, Westwood Campus Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.