A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- Progression Free Survival
研究概览
简要总结
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.
This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
详细描述
OUTLINE: This is a multi-center study.
- Cisplatin 70 mg/m2 Day 1
- Gemcitabine 1250 mg/m2 Day 1 and 8
- Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24 weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
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
- •Previously untreated or relapsed locally advanced or metastatic transitional cell carcinoma of the bladder. (Patients with pathology showing ANY component of non-transitional cell histology are not eligible).
- •Relapsed patients may have received prior chemotherapy ≥ one year prior to study registration as part of a neoadjuvant or adjuvant regimen and must not have had intervening therapy from the end of that treatment until study entry.
- •Measurable disease as per RECIST.
- •Prior radiation therapy, immunotherapy, cytokine, biologic or vaccine therapy must be greater than 28 days prior to being registered for protocol therapy,
排除标准
- •No known central nervous system metastasis. (imaging of brain only required if clinically indicated)
- •No prior organ allograft.
- •No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- •No evidence of bleeding diathesis or coagulopathy.
- •No history of serious, non-healing wound, ulcer or bone fracture
- •No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to being registered for protocol therapy.
- •No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.
- •No major surgical procedure, open biopsy, or significant traumatic injury less than 28 days prior to being registered for protocol therapy.
- •Patients are not eligible if the need for any major surgical procedure is anticipated during the course of the study.
- •Any minor surgical procedures, fine needle aspirations or core biopsies must be greater than 7 days prior to being registered for protocol therapy except procedures to secure a vascular access device which must be greater than 7 days prior to the start of protocol therapy.
研究组 & 干预措施
Single Group Assignment
Cisplatin + Gemcitabine + Bevacizumab
干预措施: Cisplatin (Drug)
Single Group Assignment
Cisplatin + Gemcitabine + Bevacizumab
干预措施: Gemcitabine (Drug)
Single Group Assignment
Cisplatin + Gemcitabine + Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 36 months
- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
次要结局
- Duration of Response for Responding Patients(36 months)
- Estimate Response Rates(36 months)
- Overall Survival Time(36 months)
研究者
Christopher Sweeney, MBBS
Sponsor-Investigator
Hoosier Cancer Research Network