Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Completed · Phase 2

Conditions studied: Gastric Cancer Adenocarcinoma Metastatic

In brief

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.

Key facts

Study ID

NCT00517829

Run by

US Oncology Research

People needed

150

Starts

2007-07-01

Expected to finish

2012-04-01

Last updated by the study team

2016-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — 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
• Texas Cancer Center at Medical City — Dallas, Texas, United States
• Texas Oncology, P.A. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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