A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer

Histologically or cytologically confirmed pancreatic adenocarcinoma. Stage IV disease. Not resectable. No clinically significant ascites. No prior chemo, hormonal, immuno, or chemoradio therapy for advanced or locally advanced pancreatic cancer. No prior gemcitabine for any reason. Prior surgery allowed if at least 14 days have elapsed. Prior adjuvant chemo allowed if at least 6 months have elapsed. Prior radiation for palliation to metastatic sites allowed if at least 28 days have elapsed and must have other untreated metastatic sites. Measurable (assessed within 28 days prior to reg) and/or non-measurable (assessed within 42 days prior to reg) disease. Must seek consent for specimen submission. Zubrod 0-1. Within 14 days prior to reg: ANC >/= 1,500/mcl; platelets >/= 100,000/mcl; hemoglobin >/= 9 g/dL; leukocytes >/= 3,000/mcl; total bilirubin </= 1 x IULN; SGOT or SGPT </= 2.5 x IULN; serum creatinine </= 1.5 x IULN or measured or estimated creatinine clearance >/= 60 ml/min; fasting serum glucose < 120 mg/dL or IULN; INR </= 1.5; PTT no more than 5 seconds above IULN. No history of allergic reaction to compounds of similar chemical or biologic composition to IMC-A12. No prior chimerized or murine monoclonal antibody therapy. No concurrent treatment with drugs that induce or inhibit CYP3A4. No plans to receive concurrent treatment for cancer. No active infections requiring antibiotics. No significant ongoing cardiac problems, MI within the last 6 months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure. No known brain mets. Not HIV positive. Not pregnant or nursing. No other prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.