A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT
研究概览
简要总结
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.
All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
- •Histology must be adenocarcinoma or squamous cell carcinoma
- •Must be surgical candidate based on evaluation by a thoracic surgeon
- •must have adequate organ function as defined by routine lab tests
排除标准
- •Insitu carcinoma
- •prior chemotherapy for esophageal cancer
- •Metastatic (stage IV disease)
- •Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within the stomach
- •Active, uncontrolled cardiac disease
- •subjects with >Grade 2 neuropathies. -
研究组 & 干预措施
Dose Level -1
Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU (Fluorouracil)
干预措施: Panitumumab (Drug)
Dose Level 1
Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)
干预措施: Panitumumab (Drug)
结局指标
主要结局
MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT
时间窗: approximately 18 weeks
Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation \>10 treatment days, 2) \>2 interruptions of radiation per course, 3) a delay in completion of radiation by \>14 days beyond planned treatment schedule, 4) inability to deliver \>80% of planned treatment doses, 5) any infield grade 4 toxicity
次要结局
- Pathologic Response(20 weeks.)