Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
- Conditions
- Gastric Cancer Adenocarcinoma Metastatic
- Interventions
- Registration Number
- NCT00517829
- Lead Sponsor
- US Oncology Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Patient has histologically confirmed Stage IV adenocarcinoma of the GEJ/stomach
Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
- Patients must have measurable disease
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- Patient is greater than 18 years of age
- If present, any pre-existing (current) peripheral neuropathy must be ≤ Grade 1
- Patient's laboratory values must fall within the limits set forth in section 4.2 of the protocol
- Patient has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
- If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a 2 month period thereafter
- Patient (or guardian) has signed a Patient Informed Consent Form
- Patient (or guardian) has signed a Patient Authorization Form
- Patient has any metastatic disease other than that defined in section 4.2 (criterion #1)
- Patient has had prior treatment that included anything other than adjuvant radiation plus treatment with 5-FU and leucovorin. Prior treatment must have been completed > 6 months prior to registration in current study. No other prior regimens are allowed.
Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
- If present, any peripheral neuropathy is > Grade 1
- Patient has a known hypersensitivity to Taxotere (or any drug formulated with Polysorbate-80), or Eloxatin
- Has had a prior severe infusion reaction (Grade 4) to a monoclonal antibody
- Has received prior therapy, at any time, which specifically and directly targets the EGFR pathway
- Patient is receiving concurrent immunotherapy or any other concurrent treatment for their cancer
- Has had prior stem cell or bone marrow transplant or any organ transplant with the exception of corneal transplant or cadaver bone graft
- Has a significant history of uncontrolled cardiac disease; ie, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (LVEF<50%)
- Has evidence of CNS involvement (CNS imaging is not required for study enrollment unless clinically suspected CNS disease is present.)
- Patient has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- Patient is known to be HIV positive or have a history of hepatitis B or C
- Patient has a history of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix , or superficial transitional cell carcinoma of the bladder), which could affect the diagnosis or assessment of current condition.
- Patient is a pregnant or lactating woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2- Docetaxel plus oxaliplatin plus cetuximab Docetaxel Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. 1- Docetaxel plus Oxaliplatin oxaliplatin Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours 1- Docetaxel plus Oxaliplatin Docetaxel Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours 2- Docetaxel plus oxaliplatin plus cetuximab cetuximab Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. 2- Docetaxel plus oxaliplatin plus cetuximab oxaliplatin Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
- Primary Outcome Measures
Name Time Method Progression-free Survival Treatment will continue until disease progression or intolerable toxicity, up to 2 years 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.
- Secondary Outcome Measures
Name Time Method Overall Survival Treatment will continue until disease progression or intolerable toxicity 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 to Response Treatment will continue until disease progression or intolerable toxicity 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.
Objective Response Rate (ORR) Treatment will continue until disease progression or intolerable toxicity. 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.
Duration of Response Treatment will continue until disease progression or intolerable toxicity 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.
Trial Locations
- Locations (43)
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Birmingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, 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
Kansas City Cancer Centers - Southwest
🇺🇸Overland Park, Kansas, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
New York Oncology Hematology, P.C.
🇺🇸Hudson, New York, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Interlakes Oncology Hematology, PC
🇺🇸Rochester, New York, United States
Cancer Centers of North Carolina
🇺🇸Raleigh, North Carolina, United States
Mahoning Valley Hematology Oncology Associates
🇺🇸Boardman, Ohio, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
Medical Oncology Associates
🇺🇸Kingston, Pennsylvania, United States
Texas Oncology, P.A. Amarillo
🇺🇸Amarillo, Texas, United States
Texas Cancer Center
🇺🇸Denton, Texas, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
Texas Oncology, P.A.
🇺🇸Garland, Texas, United States
Texas Oncology, P.A. - Bedford
🇺🇸Bedford, Texas, United States
Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
Methodist Charlton Cancer Ctr.
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Ctr
🇺🇸El Paso, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
Texas Cancer Center of Mesquite
🇺🇸Mesquite, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
Texas Oncology - Odessa
🇺🇸Odessa, Texas, United States
Fairfax Northern VA Hem-Onc PC
🇺🇸Arlington, Virginia, United States
Texas Oncology Cancer and Research
🇺🇸Waco, Texas, United States
Paris Regional Cancer Center
🇺🇸Paris, Texas, United States
Onc and Hem Associates of SW VA, Inc.
🇺🇸Salem, Virginia, United States
Puget Sound Cancer Center - Edmonds
🇺🇸Edmonds, Washington, United States
Columbia Basin Hematology & Oncology
🇺🇸Kennewicke, Washington, United States
Puget Sound Cancer Center - Seattle
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - South
🇺🇸Spokane, Washington, United States
Northwest Cancer Specialist - Vancouver
🇺🇸Vancouver, Washington, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Rocky Mountain Cancer Center - Midtown
🇺🇸Denver, Colorado, United States