Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in 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 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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer|
- MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer [ Time Frame: approximately 18 weeks ] [ Designated as safety issue: Yes ]From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
- Pathologic response [ Time Frame: 20 weeks. ] [ Designated as safety issue: No ]From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Panitumumab/Cisplatin/Fluorouracil and Radiation therapy||
dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128387
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Mark Ritter, M.D., Ph.D. 608-263-8500 firstname.lastname@example.org|
|Contact: Diana Trask, BS 608-263-9528 email@example.com|
|Principal Investigator: Mark Ritter, M.D., Ph.D|