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

IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group

INTRODUCTION

  • Org Study ID: IIT-2019-IVC_CarboGem
  • Secondary ID: N/A
  • NTC ID: NCT04046094
  • Sponsor: University of Kansas Medical Center

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    October 17, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Post Treatment Pathological Staging

Primary Outcome 1 - Timeframe: 10 weeks

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: John Taylor, MD MS

Role: Principal Investigator

Affiliation: The University of Kansas

Overall Contact

Name: John Taylor, MD MS

Phone: 913-945-7552

Email: ctnursenav@kumc.edu

LOCATION

Facility Status Contact
Facility: The University of Kansas Cancer Center (KUCC)
Fairway, Kansas 66205
United States
Status: Recruiting Contact: Contact
Clinical Trials Nurse Navigator
913-945-7552
ctnursenav@kumc.edu
Facility: The University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Steve Williamson, MD
913-588-3808
SWILLIAM@kumc.edu
Facility: The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
United States
Status: Recruiting Contact: Contact
Clinical Trials Nurse Navigator
913-945-7552
ctnursenav@kumc.edu