A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group
研究概览
简要总结
The objectives of this study are to:
- To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
- To determine the maximum-tolerated dose (MTD) when capecitabine
- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
- To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)
详细描述
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2).
In Phase 1, the objectives are to
- Assess dose-limiting toxicities (DLTs) and
- Determine a maximum-tolerated dose (MTD)
The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery.
Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all study participants at the time of, or after, surgery, as measured by the pathologic response rate; downstaging; and survival at 5 years from the start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 100 mg/m², Days 2 and 23
干预措施: Cetuximab (Drug)
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 100 mg/m², Days 2 and 23
干预措施: Oxaliplatin (Drug)
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 100 mg/m², Days 2 and 23
干预措施: Capecitabine (Drug)
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 100 mg/m², Days 2 and 23
干预措施: Radiotherapy (Radiation)
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 100 mg/m², Days 2 and 23
干预措施: Diphenhydramine hydrochloride (HCl) (Drug)
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- Cetuximab 250 mg/m² / week
- Capecitabine 700 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 85 mg/m², Days 2 and 23
干预措施: Cetuximab (Drug)
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- Cetuximab 250 mg/m² / week
- Capecitabine 700 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 85 mg/m², Days 2 and 23
干预措施: Oxaliplatin (Drug)
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- Cetuximab 250 mg/m² / week
- Capecitabine 700 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 85 mg/m², Days 2 and 23
干预措施: Capecitabine (Drug)
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- Cetuximab 250 mg/m² / week
- Capecitabine 700 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 85 mg/m², Days 2 and 23
干预措施: Radiotherapy (Radiation)
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- Cetuximab 250 mg/m² / week
- Capecitabine 700 mg/m²
- Radiotherapy (XRT)
- Oxaliplatin 85 mg/m², Days 2 and 23
干预措施: Diphenhydramine hydrochloride (HCl) (Drug)
Group A - Cetuximab + Capecitabine-800 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
干预措施: Cetuximab (Drug)
Group A - Cetuximab + Capecitabine-800 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
干预措施: Capecitabine (Drug)
Group A - Cetuximab + Capecitabine-800 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
干预措施: Radiotherapy (Radiation)
Group A - Cetuximab + Capecitabine-800 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 800 mg/m²
- Radiotherapy (XRT)
干预措施: Diphenhydramine hydrochloride (HCl) (Drug)
Group B - Cetuximab + Capecitabine-1000 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 1000 mg/m²
- Radiotherapy (XRT)
干预措施: Cetuximab (Drug)
Group B - Cetuximab + Capecitabine-1000 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 1000 mg/m²
- Radiotherapy (XRT)
干预措施: Capecitabine (Drug)
Group B - Cetuximab + Capecitabine-1000 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 1000 mg/m²
- Radiotherapy (XRT)
干预措施: Radiotherapy (Radiation)
Group B - Cetuximab + Capecitabine-1000 + XRT
- Cetuximab 250 mg/m² / week
- Capecitabine 1000 mg/m²
- Radiotherapy (XRT)
干预措施: Diphenhydramine hydrochloride (HCl) (Drug)
结局指标
主要结局
Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group
时间窗: 10 weeks
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a \< 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.
Dose-limiting Toxicity (DLT) - Number of Participants Affected
时间窗: 10 weeks
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a \< 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT.
次要结局
- Tumor Downstaging at Surgical Resection(12 to 14 weeks after radiotherapy)
- Survival at 5 Years(5 years)
- Time-to-Progression (TTP)(5 years)
- Pathologic Response Rate(12 to 14 weeks after radiotherapy)
- Overall Survival (OS)(72 months)
研究者
George Albert Fisher
Professor of Medicine and Colleen Haas Chair in the School of Medicine
Stanford University