Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 16
- 主要终点
- Objective response rate measured by RECIST at 8 weeks after completion of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.
详细描述
OBJECTIVES:
- Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer.
- Determine the objective response rate and duration of response in patients treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1-3 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not undergoing local treatment receive up to 8 courses. Patients planning to undergo surgery receive up to 4 courses.
Patients are followed every 8 weeks until disease progression and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed penile squamous cell carcinoma
- •Locally advanced or metastatic disease
- •T3, N1-2 OR T4, N3, M1
- •Measurable disease outside of any previously irradiated field
- •No clinical signs of brain metastases
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
- •Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
- •Glomerular filtration rate at least 60 mL/min
- •Gastrointestinal
- •No chronic diarrhea
- •No unresolved bowel obstruction
- •No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- •No other prior or concurrent malignancy except adequately treated skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior radiotherapy
- •No concurrent radiotherapy for pain control
- •Not specified
- •No other concurrent experimental or anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Objective response rate measured by RECIST at 8 weeks after completion of study treatment
次要结局
- Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter
- Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression