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
OBJECTIVES:
Primary
- 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
surgery.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Complete pathologic tumor response
No
Carolyn E. Reed, MD
Study Chair
Medical University of South Carolina
United States: Federal Government
CDR0000596674
NCT00757172
January 2009
Name | Location |
---|---|
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 |