NCT00276588已完成2 期
Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with carboplatin followed by paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in regard to response rate, median survival, and one year survival.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is multicenter study.
- Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. In week 7, all patients proceed to part 2 regardless of disease response.
- Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 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 confirmed non-small lung cancer (NSCLC) of any of the following histologic types:
- •Squamous cell
- •Adenocarcinoma
- •Large cell carcinoma
- •Unspecified
- •Evidence of at least 1 of the following criteria:
- •Newly diagnosed inoperable stage IIIB (pleural effusion) disease
- •Patients with stage III disease who are unable to undergo combined modality therapy
- •Stage IV disease
- •Recurrent non-small cell lung cancer regardless of site
- •Diagnosis based on sputum cytology acceptable if confirmed by an independent pathologic review
- •Patients must have measurable or evaluable disease
- •Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present
- •Patients with brain metastases are eligible, provided they are either asymptomatic (no neurological symptoms or signs, no evidence of midline shift), or controlled (i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid therapy for at least two weeks with no evidence of progression by symptoms or radiologic imaging
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 2 or 3 OR HIV-positive OR underwent prior status post organ transplantation
- •No active serious infection (except for HIV infection)
- •No symptomatic, untreated malignant pericardial effusion
- •No congestive heart failure
- •No other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm ^3
- •Creatinine clearance ≥ 40 mL/min
- •Creatinine ≤ 1.8 mg/dL
- •Bilirubin < 1.5 mg/dL
- •SGOT ≤ 2 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Males or females of reproductive potential may not participate unless they have agreed to use effective barrier contraceptive methods
- •No prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior chemotherapy is not allowed
- •At least three weeks since prior radiotherapy and recovered from all toxicities
- •At least three weeks must have elapsed from major surgery and recovered from all adverse effects of surgery
- •No prior colony-stimulating factors or interferon
- •No concurrent hormonal, biologic, or radiotherapy to measurable lesions
- •Patients may receive concurrent palliative radiotherapy to small-field nonmeasurable sites of disease (e.g., painful bony metastases)
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
Time to progression
Time to treatment failure
Overall survival
次要结局
- Duration of response (complete response and partial response)
研究者
研究点 (2)
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