Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 67
- 主要终点
- Best Overall Response by RECIST Criteria (Version 1.0)
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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.
- Determine the duration of response in these patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.
Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
- •Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
- •Advanced limited disease allowed if ineligible for primary radiotherapy or surgery
- •Measurable disease
- •Age 18 and over
- •ECOG Performance Status 0-1
- •Granulocyte count at least 1,500 cells/mm^3
- •Platelet count at least 100,000 cells/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed
排除标准
- •Acute concurrent complications such as infection or post-surgical complications
- •Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
- •Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception
- •Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year
研究组 & 干预措施
Paclitaxel plus Carboplatin
Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
干预措施: carboplatin (Drug)
Paclitaxel plus Carboplatin
Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
干预措施: paclitaxel (Drug)
结局指标
主要结局
Best Overall Response by RECIST Criteria (Version 1.0)
时间窗: Assessed every 2 cycles (6 weeks)
Number of eligible, treated participants in each response category by RECIST criteria
次要结局
- Duration of Response(assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter)