Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Irinotecan, oxaliplatin, and cetuximab
Intervention description: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days.
Intervention MeSH terms: Oxaliplatin; Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Irinotecan; Oxaliplatin; Cetuximab; Advanced or metastatic pancreatic cancer

Summary:

      This phase II trial studies the side effects and how well irinotecan hydrochloride,
      oxaliplatin and cetuximab work in treating patients with unresectable or metastatic
      pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
      in different ways. Some block the ability of tumor to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Giving irinotecan
      hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients, 18 years of age or older, with histology proven pancreatic cancer are
             eligible.

          2. Patients must have a life expectancy of at least 12 weeks.

          3. Patients must have a Zubrod performance status of 0-2.

          4. Patients must sign an informed consent.

          5. Patients should have adequate bone marrow function defined by an absolute peripheral
             granulocyte count of >= 1,500 or cells/mm3 and platelet count >= 60,000/mm3 and
             absence of a regular red blood cell transfusion requirement.

          6. Patients should have adequate hepatic function with a total bilirubin <= 4.0 mg/dl,
             could be <= 10 mg/ml if biliary drainage tube is placed and functional in a newly
             diagnosed patient, and SGOT or SGPT <= four times the upper limit of normal, and
             adequate renal function as defined by a serum creatinine <= 1.5 x upper limit of
             normal.

          7. For patients that had been treated with one of the study medications will be allowed
             as long as the treatment did not contain more than 2 study medications at the same
             time. For example, irinotecan and capecitabine combination will be allowed but not
             irinotecan and cetuximab. Similarly, gemcitabine with cetuximab will be allowed but
             not gemcitabine, oxaliplatin and cetuximab. Treated with irinotecan alone followed by
             oxaliplatin will be allowed but not when irinotecan was in combination with
             oxaliplatin.

          8. Patients are allowed to have up to 2 prior treatments. The protocol will also include
             chemotherapy naïve patients.

        Exclusion Criteria:

          1. Patients with symptomatic brain metastases are excluded from this study.

          2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child
             bearing potential must use adequate contraception.

          3. Patients may receive no other concurrent chemotherapy or radiation therapy during this
             trial.

          4. Patients with severe medical problems such as uncontrolled diabetes mellitus or
             cardiovascular disease or active infections are not eligible for this trial.

          5. Known hypersensitivity reaction to any of the study medications.