A Phase I Dose Escalation Study of Capecitabine, Carboplatin and Weekly Paclitaxel and a Phase II Trial of the Same Combination in Patients With Adenocarcinoma of Unknown Primary
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose in Phase I Portion of Study
研究概览
简要总结
This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.
详细描述
Rationale: The combination of the chemotherapy drugs paclitaxel and carboplatin is one of the most common combination regimens used in clinical practice for cancer. These agents are used for a variety of cancers. The current study builds on previous research about treatment schedules for administering these agents to reduce toxicity and optimize efficacy. The phase I and II portions of the current study combine paclitaxel and carboplatin with capecitabine in patients. Researchers are seeking to identify the highest dose of capecitabine and paclitaxel in combination with carboplatin for this patient population, as well as to gather information about preliminary efficacy.
Purpose: The phase I portion of this study will evaluate the maximum tolerated dose of capecitabine and paclitaxel in combination with carboplatin for patients. The phase II portion of this study will assess the objective response rate in patients using the same treatment combination. Toxicities will be closely measured in both phases of the study.
Treatment: Patients in this study will be given capecitabine, carboplatin, and paclitaxel. Capecitabine will be given through oral pills. Carboplatin and paclitaxel will be given through intravenous infusions. Treatment drugs will be given on a four-week cycle. Carboplatin will be administered on day 1, paclitaxel weekly for the first 3 weeks, and capecitabine twice daily on days 8 through 21 of each cycle. No treatments will be given during the fourth week of each treatment cycle. During the phase I portion of the study, patients may receive different doses of capecitabine and paclitaxel since the purpose is to identify the maximum tolerated dose of each drug in combination with carboplatin. Once the maximum tolerated dose of these agents is identified during phase I, the phase II portion of the study will begin. Treatments will be discontinued due to disease growth or unacceptable side effects. Several tests and exams will be given throughout the study to closely monitor patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, carboplatin IV over 1-2 hours on day 1, and capecitabine PO BID on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
Arm I
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, carboplatin IV over 1-2 hours on day 1, and capecitabine PO BID on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
Arm I
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, carboplatin IV over 1-2 hours on day 1, and capecitabine PO BID on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Maximum Tolerated Dose in Phase I Portion of Study
时间窗: Every 3 weeks, for up to 24 weeks
Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.
Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.
时间窗: Every 3 weeks, for up to 24 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
- Phase I: To Determine Side Effects(Every 3 weeks, for up to 24 weeks)
- Progression-Free Survival at 6 Months for Patients(up to 6 years)
- One Year Survival for Patients(Up to 1 year)
- Time to Tumor Progression for Patients(Up to 6 years)
研究者
Tony Bekaii-Saab
Principal Investigator
Ohio State University Comprehensive Cancer Center