Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2007-07-31
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1- Docetaxel plus Oxaliplatin
Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours
Docetaxel
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
oxaliplatin
Eloxatin 130 mg/m2 IV over 2 hours
2- Docetaxel plus oxaliplatin plus 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.
Docetaxel
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
cetuximab
ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
oxaliplatin
Eloxatin 130 mg/m2 IV over 2 hours
Interventions
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Docetaxel
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
cetuximab
ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
oxaliplatin
Eloxatin 130 mg/m2 IV over 2 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sanofi
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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Principal Investigators
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Donald A Richards, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Texas Cancer Center
Arlington, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology, P.A. - Bedford
Bedford, Texas, United States
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
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
New York Oncology Hematology, P.C.
Hudson, New York, 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 at Medical City
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Texas Oncology - Odessa
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer and Research
Waco, Texas, United States
Fairfax Northern VA Hem-Onc PC
Arlington, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, 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
Countries
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References
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Richards D, Kocs DM, Spira AI, David McCollum A, Diab S, Hecker LI, Cohn A, Zhan F, Asmar L. Results of docetaxel plus oxaliplatin (DOCOX) +/- cetuximab in patients with metastatic gastric and/or gastroesophageal junction adenocarcinoma: results of a randomised Phase 2 study. Eur J Cancer. 2013 Sep;49(13):2823-31. doi: 10.1016/j.ejca.2013.04.022. Epub 2013 Jun 5.
Other Identifiers
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06063
Identifier Type: -
Identifier Source: org_study_id