A Phase II Study of Non-Small Cell Cancer of the Lung Utilizing Low-Dose Weekly Therapy of Taxotere and Carboplatin
试验速览
- 阶段
- 2 期
- 入组人数
- 38
- 试验地点
- 2
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 combining docetaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES: I. Determine the effectiveness of low dose docetaxel and carboplatin by response rate, response duration, and time to progression in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the side effects and toxicity profile of docetaxel when given in combination with carboplatin in these patients.
OUTLINE: This is open label study. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 30 minutes once a week for 4 weeks. Patients receive at least 2 courses (8 weeks) of treatment. Courses are further repeated in the absence of unacceptable toxicity and disease progression.
PROJECTED ACCRUAL: There will be 20-38 patients accrued into this study.
研究设计
- 研究类型
- Interventional
- 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 confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients
- •PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective criteria for disease progression Surgery: Not specified Other: No other concurrent experimental drug
排除标准
- 未提供