Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2010 |
| End Date: | October 2016 |
A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
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).
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).
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. -
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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