5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
- Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value
- •Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST less than 2 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •Lactic dehydrogenase less than 2 times ULN
- •Creatinine no greater than 1.5 times ULN
- •HIV negative
- •No active uncontrolled bacterial, viral, or fungal infection
- •No nonmalignant systemic disease that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No prior irinotecan
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control
- •No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture)
- •See Disease Characteristics
- •At least 2 weeks since prior major surgery
- •No concurrent anticoagulants except warfarin or subcutaneous heparin
排除标准
- 未提供