A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus
- To determine the pathologic complete response rate in patients with newly diagnosed,
locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction
treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by
- To determine the near-complete pathologic response rate in the primary tumor (≤ 10%
residual viable cancer).
- To determine the overall survival and disease-free survival rates of these patients.
- To determine the safety profile of this regimen.
OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and
cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo
radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of
metastatic disease undergo esophagectomy.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year OR every 6 months for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Complete pathologic tumor response
Carolyn E. Reed, MD
Medical University of South Carolina
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Central Baptist Hospital||Lexington, Kentucky 40503|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Simmons Cooper Cancer Institute||Springfield, Illinois 62794-9677|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Legacy Emanuel Hospital and Health Center and Children's Hospital||Portland, Oregon 97227|
|Geisinger Cancer Institute at Geisinger Health||Danville, Pennsylvania 17822-0001|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|
|Good Samaritan Hospital||Dayton, Ohio 45406|
|Charles F. Kettering Memorial Hospital||Kettering, Ohio 45429|
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|Wayne Hospital||Greenville, Ohio 45331|