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Vitamin C

IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks

John Taylor, MD MS

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.

To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.

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

Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.

Scores evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores:

* FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL.
* FACT-Bl includes five sub-scales:

  * Physical Well-being (PWB), score range of 0-28
  * Social/Family Well-being (SWB), score range of 0-28
  * Emotional Well-being (EWB), score range of 0-24
  * Functional Well-being (FWB), score range of 0-28
  * Bladder Cancer Subscale (BlCS), score range of 0-48
* Note: Negatively stated items are reversed by subtracting the response from "4".

DFS will be defined as time from cystectomy to disease recurrence or death resulting from disease. DFS represents time from random assignment to cancer recurrence or death from any cause. Patients alive without disease progression at the time of analysis were censored at the date of last disease assessment.

National Center for Advancing Translational Sciences (NCATS)

University of Kansas Medical Center

Professor, Director of Basic Urologic Research, Co-Leader of D3ET

IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks

Ascorbic Acid: Ascorbic Acid Intravenous

Spots Global Cancer Trial Database for intravenous (iv) ascorbic acid (vitamin c)