Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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
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.
研究概览
详细说明
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.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore、Maryland、美国、21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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进展时间
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治疗失败时间
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无进展生存期
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总生存期
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次要结果测量
结果测量 |
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Duration of response (complete response and partial response)
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合作者和调查者
调查人员
- 首席研究员:Julie Brahmer, MD、Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- JHOC-J0428, CDR0000450843
- P30CA006973 (美国 NIH 拨款/合同)
- JHOC-J0428
- BMS-JHOC-J0428
- JHOC-BRAAN-21048
- MSGCC-0060
- JHOC-04112308
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