A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 31
- 主要终点
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
研究概览
简要总结
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
详细描述
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:
- Paclitaxel + Carboplatin + Etoposide
- Irinotecan + Gemcitabine
Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •To be included in this study, you must meet the following criteria:
- •Carcinoma of unknown primary site
- •Biopsy-proven metastatic carcinoma
- •Able to perform activities of daily living with minimal assistance
- •No previous treatment with any systemic therapy
- •Measurable or evaluable disease
- •Adequate bone marrow, liver and kidney function
- •Understand the nature of this study and give written informed consent
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years
- •Uncontrolled brain metastases and meningeal involvement
- •Other uncontrolled malignancies
- •Women pregnant or lactating
- •Recent history of significant cardiovascular disease
- •Severe or uncontrolled systemic disease
- •Other significant clinical disorder
- •Clinically active interstitial lung disease
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
研究组 & 干预措施
Regimen A
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
干预措施: Etoposide (Drug)
Regimen A
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
干预措施: Paclitaxel (Drug)
Regimen A
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
干预措施: Carboplatin (Drug)
Regimen B
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
干预措施: Gemcitabine (Drug)
Regimen B
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
时间窗: 24 months
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
次要结局
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease(12 months)