Clinical Trials /

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

NCT04046094

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.

Related Conditions:
  • Infiltrating Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04046094

Trial Eligibility

Document

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

  • Bladder Cancer

Interventions

DrugSynonymsArms
Ascorbic AcidVitamin CIV 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

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

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