Phase II Trial Of CAPOX+Bevacizumab+Trastuzumab For Patients With HER2-Positive Metastatic Esophagogastric Cancer.
Primary objective is to determine the major response rate of CAPOX plus bevacizumab plus trastuzumab for patients with HER2 positive metastatic or unresectable esophagogastric adenocarcinoma. The toxicity profile, duration of response and rate of median, overall and progression free survival will also be evaluated.
Confirmed stage HER2-postitive esophageal, GE junction or gastric adenocarcinoma (including undifferentiated and adenosquamous carcinoma the is metastatic or unresectable. Testing using IHC or FISH. Must have available tumor sample prior to study entry. Normal blood and organ functions. LVEF greater than 50%. No active brain metastases; uncontrolled hypertension or evidence of bleeding. Arterial thrombus, CVA,TIA, MI or unstable angina in the past 6 months. Low molecular weight heparin is allowed (warfarin is not allowed). No prior treatment with : Capecitabine, oxaliplatin, bevacizumab or trastuzumab. May have received and completed adjuvant therapy at least 6 months prior to study entry or one prior therapy for metastatic disease.
Trastuzumab IV loading dose on Day 1 with the next cycle starting after 7 days. Cycles will begin with: Bevacizumab IV, Trastuzumab IV, Oxaliplatin IV given in this order. Capeciatbine will be given orally on day 1 of the cycle starting after the oxaliplatin. Dosing will be continuous on 3-week (21 day) cycles on an individual basis until evidence of progressive disease or unacceptable toxicity.
09/19/2014 04:03 AM