Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Oncology Research
• Collaborators: Eli Lilly and Company; ImClone LLC; Sanofi
• Treatments: Cetuximab; Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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