Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
研究概览
简要总结
Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.
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
- •Patients able to consent in English or Spanish; provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female ages ≥18 years.
- •Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
- •Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-
- •Post-transurethral bladder tumor resection.
- •Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
排除标准
- •Known hypersensitivity reaction to gemcitabine and/or docetaxel.
- •Clinical T2 or higher stage UC of the bladder.
- •Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
- •Active malignancies other than the disease being treated under study.
- •Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
- •Pregnant or breast-feeding women.
- •Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
研究组 & 干预措施
Gemcitabine induction
Patients will receive Gemcitabine + Docetaxel once weekly for 6 weeks.
干预措施: gemcitabine + docetaxel (Drug)
结局指标
主要结局
Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
时间窗: Complete response rate will be measured at the 3-month visit
The primary outcome measure will be CR rate, defined as the percentage of patients with CR at the 3-month visit. An event will be defined as the earliest date of recurrence as determined using the date of cystoscopy, biopsy, or cytology, whichever occurs first.
次要结局
- Durability of response in patients who achieve CR(Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation)
- Tolerability and safety of the treatment(Toxicity assessment will be evaluated at the 3-month visit)
- Proportion of patients who accept maintenance therapy(The assessment will be done at the 3-month visit)
- Rate and reasons for cystectomy (if any)(Through study completion, an average of 1 year)