Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.
- Assess the toxicity of this combination regimen in this patient population.
- Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.
OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT 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 toxicities.
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 or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists
- •Evaluable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm3
- •Platelet count greater than 100,000/mm3
- •Hemoglobin greater than 8.0 mg/dL
- •Bilirubin less than 2.0 mg/dL
- •AST less than 3.0 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •No active infection requiring antibiotics
- •Not pregnant or nursing
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered
- •No prior gemcitabine
- •Endocrine therapy:
- •Prior hormonal therapy allowed
- •No concurrent hormonal contraception
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered
- •Prior major surgery allowed and recovered
- •No prior or concurrent antiviral nucleosides
排除标准
- 未提供