Gastric Cancer Adenocarcinoma Metastatic Clinical Trial
Official title:
Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.
This is a Phase II, open- label, randomized, noncomparative study. Patients will be
stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients
for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that
the 2 treatment arms are well-balanced for ECOG PS.
Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous
(IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 -
Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2
hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses
are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day
cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle.
Treatment will continue until disease progression or intolerable toxicity. Patients who
achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to
24 months of participation, counted from the date of the first dose of study drug.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment