This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36
Clopton Clinic
Jonesboro, Arkansas, United States
Response Rate
The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.
Time frame: From the start of study treatment until restaging evaluation performed between days 36 to 43
Pathologic Response Rate
The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H\&E) examination.
Time frame: At time of surgery (between days 50 to 64)
Resection Rate of Surgery
The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H\&E)examination, and the operative report indicates complete resection with no residual disease. The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H\&E) examination, and the operative report indicates complete resection with no residual disease. The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease.
Time frame: At time of surgery (between days 50 to 64)
Thirty-day Surgical Mortality
All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.
Time frame: From date of surgery to 30 days after date of surgery
Survival
Time frame: 2-year survival from first dose of panitumumab
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