A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
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, and leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or lymphomas.
详细描述
OBJECTIVES:
- Determine the clinical toxic effects associated with administering sequential gemcitabine followed by fluorouracil with leucovorin calcium in patients with refractory or recurrent or metastatic solid tumors or lymphomas.
- Determine achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the pharmacodynamics of gemcitabine and fluorouracil in these patients.
OUTLINE: This is a dose-escalation study of fluorouracil and gemcitabine.
During the first course, patients receive gemcitabine IV over 30 minutes once weekly for 2 weeks followed by one week of rest. During subsequent courses, patients receive gemcitabine as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks. Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of fluorouracil is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of fluorouracil and then gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.
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:
- •Diagnosis of cancer that has failed standard therapy or for which no such therapy exists, including, but not limited to:
- •Unresectable primary or recurrent solid tumors (e.g., colon, pancreatic, lung, esophageal, or cholangiocarcinoma)
- •Metastatic disease
- •Lymphoma with no prior high-dose chemotherapy requiring autologous or allogeneic stem cell rescue
- •No leukemias
- •No CNS metastases or primary CNS malignancies
- •No failure on prior gemcitabine therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •Transaminases less than 6 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other serious concurrent medical illness that would preclude study
- •No active infections requiring IV antibiotics
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •More than 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy (at least 6 weeks for mitomycin or nitrosoureas) and recovered
- •At least 3 months since prior suramin
- •At least 5 weeks since prior eniluracil (8 weeks prior to start of fluorouracil) and recovered
- •Endocrine therapy:
- •No steroid therapy if utilized for chronic lymphoma therapy
- •At least 4 weeks since prior steroidal therapy as disease treatment
- •Radiotherapy:
- •At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow
- •At least 4 weeks since prior radiotherapy to 21% or more of bone marrow
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •No concurrent cimetidine
排除标准
- 未提供