A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection.
PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.
详细描述
OBJECTIVES:
- Determine whether prophylactic treatment with levofloxacin reduces the rate of clinical infection in patients receiving myelosuppressive antineoplastic chemotherapy for solid tumors or lymphoma.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to age (under 40 vs 40-59 vs 60 and over), type of cancer (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs breast vs germ cell vs small cell lung cancer vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral levofloxacin once daily for 7 consecutive days during the expected neutrophil nadir of each chemotherapy course.
- Arm II: Patients receive an oral placebo once daily for 7 consecutive days as in arm I.
Treatment in both arms continues for up to 6 courses in the absence of unacceptable side effects or allergy or a clear continuing indication for the prophylactic use of antibacterial agents during subsequent courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of solid tumor, including but not limited to, the following:
- •Stage II-IV germ cell malignancy
- •Small cell lung cancer
- •Recurrent breast cancer OR
- •Diagnosis of lymphoma
- •About to start a program of antineoplastic chemotherapy for malignant disease that will regularly induce myelosuppression with a risk of temporary severe neutropenia (i.e., neutrophil count less than 500/mm3), but does not routinely require filgrastim (G-CSF) or stem cell support
- •Not previously randomized into the Significant trial for a different multicourse chemotherapy program
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Creatinine normal OR
- •Creatinine clearance greater than 40 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception in addition to oral contraceptive pills
- •HIV negative
- •No epilepsy
- •No history of adverse events resulting from fluoroquinolone therapy (e.g., allergy or tendinitis)
- •No concurrent use of a sunbed or exposure to strong sunlight
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No other concurrent antibacterial therapy
- •No other concurrent prophylactic antibacterial agents including cotrimoxazole prophylaxis against Pneumocystis carinii
- •No iron supplements, sucralfate, or mineral antacids 2 hours before or after study medication
- •Concurrent entry into other clinical trials allowed
排除标准
- 未提供