Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Patient simultaneously enrolled in any therapeutic clinical trial - Current or anticipated use of other investigational agents while participating in this study - Psychiatric illness/social situations that would limit compliance with study requirements - 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 - Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder - Uncontrolled intercurrent illness - Current consumption of tobacco products - History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IV Ascorbic Acid
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
  • Drug: Ascorbic Acid
    Ascorbic Acid Intravenous
    Other names:
    • Vitamin C

More Details

Status
Active, not recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Detailed Description

see protocol

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.