IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Post Treatment Pathological Staging
研究概览
简要总结
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.
详细描述
see protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IV Ascorbic Acid
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Post Treatment Pathological Staging
时间窗: 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.
次要结局
- Disease Free Survival Rate (DFS) Among Participants(5 years)
- Overall Change in Patient-reported Quality of Life Outcomes(Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative))
研究者
John Taylor
Professor, Director of Basic Urologic Research, Co-Leader of D3ET
University of Kansas Medical Center