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

Study Overview
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Brief Summary
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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
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IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: Ascorbic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Ascorbic Acid<br>IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks | Drug: Ascorbic Acid<br>* Ascorbic Acid Intravenous<br>* Other names: Vitamin C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Treatment Pathological Staging | Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall change in patient-reported quality of life outcomes | 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. | 8 weeks | 
| Disease free survival rate (DFS) among participants | Medical Record | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous (IV) Ascorbic Acid (Vitamin C)