NCT00030433已完成2 期
Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 203
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 II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
- Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
- Determine the overall toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
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 confirmed extensive stage small cell lung cancer (SCLC)
- •Malignant pleural effusion constitutes extensive stage disease
- •Must have disease outside area of prior surgical resection or a new lesion must be present
- •Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)
- •Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN
- •Not specified
- •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 other adequately treated stage I or II cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy for SCLC
- •Chemotherapy:
- •No prior systemic chemotherapy for SCLC
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy for SCLC except for brain metastases
- •See Disease Characteristics
- •At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
排除标准
- 未提供
研究者
研究点 (203)
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