Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in Esophageal Cancer
This trial has been completed.
|Phase||phase 1/phase 2|
|Sponsor||University of Wisconsin, Madison|
|Start date||May 2010|
|End date||October 2016|
|Trial size||11 participants|
|Trial identifier||NCT01128387, H-2009-0214, RO09211|
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 imaging to predict the degree of pathologic response.
All patients will have a pre-study FDG 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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer
time frame: approximately 18 weeks
time frame: 20 weeks.
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N) 2. Histology must be adenocarcinoma or squamous cell carcinoma 3. Must be surgical candidate based on evaluation by a thoracic surgeon 4. must have adequate organ function as defined by routine lab tests Exclusion Criteria: 1. Insitu carcinoma 2. prior chemotherapy for esophageal cancer 3. Metastatic (stage IV disease) 4. Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within the stomach 5. Active, uncontrolled cardiac disease 6. subjects with >Grade 2 neuropathies. -
|Official title||A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer|
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