INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer
1. All patients, 18 years of age or older, with histology proven pancreatic cancer are
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
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
8. Patients are allowed to have up to 2 prior treatments. The protocol will also include
chemotherapy naïve patients.
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
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.