Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 85
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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
详细描述
OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 proven, previously untreated extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR Previously treated with radiotherapy and/or surgery Measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is in complete remission
- •PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and recovered
排除标准
- 未提供