Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: cetuximab; docetaxel; irinotecan hydrochloride
Intervention description: Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.; Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.; After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.
Intervention MeSH terms: Docetaxel; Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cancer; metastatic pancreatic cancer; EGF-r; irinotecan; docetaxel; cetuximab

Summary:

      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 .
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 lesionge

          -  Age of 18 and over

          -  ECOG performance status 0-1

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Creatinine clearance > 60 mL/min

          -  LVEF normal

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  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

        Exclusion Criteria:

          -  History of uncontrolled arrhythmias

          -  History of congestive heart failure

          -  History of uncontrolled angina pectoris

          -  Prior chemotherapy

          -  Pre-existing neuropathy ≥ grade 2

          -  Prior hypersensitivity to polysorbate 80

          -  Pregnant or nursing