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NCT Number: NCT04046094

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Kansas Cancer Center (KUCC), Fairway, Kansas, United States

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About this study

see protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

Ascorbic Acid Intravenous

Other names: Vitamin C

Primary outcomes

  1. Post Treatment Pathological Staging

    Time frame: 6 weeks after first IVC infusion at radical cystectomy

    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.

Secondary outcomes

  1. Overall Change in Patient-reported Quality of Life Outcomes

    Time frame: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)

    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".

  2. Disease Free Survival Rate (DFS) Among Participants

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Aug 6, 2019
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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