Description:
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.
Title
- Brief Title: Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
- Official Title: IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
Clinical Trial IDs
- ORG STUDY ID:
IIT-2019-IVC_CarboGem
- NCT ID:
NCT04046094
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Ascorbic Acid | Vitamin C | IV Ascorbic Acid |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
IV Ascorbic Acid | Experimental | IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Post Treatment Pathological Staging |
Time Frame: | 10 weeks |
Safety Issue: | |
Description: | Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines |
Secondary Outcome Measures
Measure: | Overall change in patient-reported quality of life outcomes |
Time Frame: | 8 weeks |
Safety Issue: | |
Description: | 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". |
Measure: | Disease free survival rate (DFS) among participants |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Medical Record |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Kansas Medical Center |
Trial Keywords
- Intravenous (IV) Ascorbic Acid (Vitamin C)
Last Updated
May 4, 2021