Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the progression-free survival produced by the combination of docetaxel (Taxotere) + oxaliplatin (Eloxatin) + cetuximab (ERBITUX)
Treatment will continue until disease progression or intolerable toxicity
No
Donald A Richards, MD
Principal Investigator
US Oncology Research
United States: Institutional Review Board
06063
NCT00517829
July 2007
September 2011
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Ocala Oncology Center | Ocala, Florida 34474 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Tyler Cancer Center | Tyler, Texas 75702 |
Hope Center | Terre Haute, Indiana 47809 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
Hematology Oncology Associates of Illinois | Skokie, Illinois 60077 |
Medical Oncology Associates | Kingston, Pennsylvania 18704 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
Texas Cancer Center at Medical City | Dallas, Texas 75230 |
Allison Cancer Center | Midland, Texas 79701 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Greater Dayton Cancer Center | Kettering, Ohio 45409 |
Birmingham Hematology and Oncology | Birmingham, Alabama 35235 |
Rocky Mountain Cancer Center - Midtown | Denver, Colorado 80218 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Texas Cancer Center | Abilene, Texas 79606 |
Texas Oncology Cancer Center | Austin, Texas 78731 |
Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
Lake Vista Cancer Center | Lewisville, Texas 75067 |
Longview Cancer Center | Longview, Texas 75601 |
Texas Cancer Center of Mesquite | Mesquite, Texas 75150 |
Onc and Hem Associates of SW VA, Inc. | Salem, Virginia 24153 |
Puget Sound Cancer Center - Edmonds | Edmonds, Washington 98026 |
Paris Regional Cancer Center | Paris, Texas 75460 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Interlakes Oncology Hematology, PC | Rochester, New York 14623 |
Texas Oncology, P.A. - Bedford | Bedford, Texas 76022 |
El Paso Cancer Treatment Ctr | El Paso, Texas 79915 |
Fairfax Northern VA Hem-Onc PC | Fairfax, Virginia 22031 |
Cancer Centers of North Carolina | Raleigh, North Carolina 27607 |
Methodist Charlton Cancer Ctr. | Dallas, Texas 75237 |
Mahoning Valley Hematology Oncology Associates | Boardman, Ohio 44514 |
Texas Oncology - Odessa | Odessa, Texas 79761 |
Texas Oncology, P.A. Amarillo | Amarillo, Texas 79106 |
Texas Oncology Cancer and Research | Waco, Texas 76712 |
Columbia Basin Hematology & Oncology | Kennewicke, Washington 99336 |
Puget Sound Cancer Center - Seattle | Seattle, Washington 98133 |
Cancer Care Northwest - South | Spokane, Washington 99202 |
Northwest Cancer Specialist - Vancouver | Vancouver, Washington 98684 |