Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
试验速览
- 阶段
- 1 期
- 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 tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Assess any therapeutic activity in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional patients are treated at this dose level.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic carcinoma of the colon or rectum
- •Recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 5 times ULN
- •PT/aPTT no greater than 1.2 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 50 mL/min
- •No impaired renal function
- •Cardiovascular:
- •No impaired cardiac function
- •No active infection
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
- •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 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •Not specified
- •No other concurrent anticancer drugs
- •No concurrent chronic non-steroidal anti-inflammatory agents
- •No concurrent chronic therapeutic anticoagulation
排除标准
- 未提供