NCT00003696Unknown3 期
Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
Commissie Voor Klinisch Toegepast Onderzoek2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 1998年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 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 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 which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer.
- Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks.
- Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks.
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 proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases
- •Measurable or evaluable disease
- •Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases)
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No cardiac failure or rhythm disturbances requiring medication
- •No history of hypersensitivity to castor oil
- •No active uncontrolled infection
- •No nonmalignant disease presenting a poor medical risk
- •Not pregnant
- •Fertile patients must use effective contraception during and for 3 months after the study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field)
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Response rate
- Duration of response
- Toxicity
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph NodesBreast CancerNCT00004125Eastern Cooperative Oncology Group
已完成
2 期
Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone CancerKidney CancerSarcomaNCT00002466Memorial Sloan Kettering Cancer Center
Unknown
2 期
Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone TherapyPainProstate CancerNCT00005960Amgen
已完成
1 期
High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Breast CancerBreast CancerNCT00002837M.D. Anderson Cancer Center21
已完成
3 期
S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian CancerOvarian CancerPeritoneal Cavity CancerNCT00043082SWOG Cancer Research Network61