Conditions: Gastroesophageal Adenocarcinoma Adenocarcinoma of the Distal Esophagus Adenocarcinomas of the Gastroesophageal Junction Adenocarcinoma of the Proximal Stomach
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 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

Interventions: intervention 1: Panitumumab intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: 5FU
Intervention descriptions: intervention 1: Panitumumab 9mg/kg on Days 1, 22, and 43 intervention 2: Paclitaxel 200mg/m2 on Days 1 and 22 intervention 3: Carboplatin AUC=6 on Days 1 and 22 intervention 4: 5FU 225mg/m2/day on Days 1-15 and 22-36

Protocol document: