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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
Eloxatin 130 mg/m2 IV over 2 hours
Progression-free Survival
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Treatment will continue until disease progression or intolerable toxicity, up to 2 years
Overall Survival
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time frame: Treatment will continue until disease progression or intolerable toxicity
Objective Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: Treatment will continue until disease progression or intolerable toxicity.
Time to Response
For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
Time frame: Treatment will continue until disease progression or intolerable toxicity
Duration of Response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
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Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Rocky Mountain Cancer Center - Midtown
Denver, Colorado, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Hope Center
Terre Haute, Indiana, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States
...and 37 more locations
Time frame: Treatment will continue until disease progression or intolerable toxicity