• Response rate by RECIST every 12 weeks [ Designated as safety issue: No ]
• Objective partial or complete response as measured by scan at 6 weeks [ Designated as safety issue: No ]

• Response rate by RECIST every 12 weeks
• Objective partial or complete response as measured by scan at 6 weeks

• Time to progression by RECIST criteria [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]
• Proportion of epidermal growth factor receptor-positive tumors [ Designated as safety issue: No ]
• Rate of thromboembolic events [ Designated as safety issue: No ]

• Time to progression by RECIST criteria
• Overall survival
• Proportion of epidermal growth factor receptor-positive tumors
• Rate of thromboembolic events

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

OBJECTIVES:

• Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas.
• Determine the time to progression and overall survival of patients treated with these regimens.
• Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Patients also receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22.
• Arm II (closed to accrual as of 4/13/06): Patients receive docetaxel and irinotecan as in arm I.

Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) (arm II closed to accrual as of 4/13/06) will be accrued for this study.

• Biological: cetuximab
• Drug: docetaxel
• Drug: irinotecan hydrochloride

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic adenocarcinoma of the pancreas
• Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing
• At least 1 unidimensionally measurable primary or metastatic lesion

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)*

• SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*:

  • SGOT or SGPT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
  • SGOT or SGPT ≤ 1.5 times ULN AND alkaline phosphatase > ULN but ≤ 2.5 times ULN
  • SGOT or SGPT ≤ ULN AND alkaline phosphatase > 2.5 but ≤ 4 times ULN NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests

Renal

• Creatinine clearance > 60 mL/min

Cardiovascular

• No history of uncontrolled arrhythmias
• No history of congestive heart failure
• No history of uncontrolled angina pectoris
• LVEF normal

Other

• No pre-existing neuropathy ≥ grade 2
• No prior hypersensitivity to polysorbate 80
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified