NCT00055965Unknown3 期
A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of hospitalization due to toxicity
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. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.
PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin.
- Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens.
- Compare the tumor response rate of patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the relief of tumor-related symptoms in patients treated with these regimens.
- Compare the effect on Karnofsky performance status in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 inoperable non-small cell lung cancer
- •Stage IIIA, IIIB, or IV
- •Not eligible for curative radiotherapy or surgery
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 50-100%
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than ULN OR
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study completion
- •No active infection
- •No serious systemic disorder that would preclude study participation
- •No grade 2 or greater peripheral neuropathy
- •No significant neurological problems (e.g., seizures or psychiatric disorders)
- •No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior cytotoxic chemotherapy
- •No other concurrent chemotherapy during or for 7 days after study therapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy
- •No concurrent radiotherapy during or for 7 days after study therapy
- •See Disease Characteristics
- •At least 12 weeks since prior investigational agents
- •No other concurrent antitumor therapy
- •No concurrent experimental medications
排除标准
- 未提供
结局指标
主要结局
Rate of hospitalization due to toxicity
次要结局
- Need for hospitalization for chemotherapy administration
- Effect on Karnofsky performance status
- Relief of tumor-related symptoms
- Tumor response rate
- Toxicity as measured by NCIC CTC v2.0
- Overall survival
研究者
研究点 (1)
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