S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

You may be eligible if

• Histologically or cytologically confirmed pancreatic adenocarcinoma
• * Stage IV disease (any T, any N, M1 \[distant metastases\])
• * Unresectable disease
• * Histologic diagnosis based on a metastatic site must be compatible with pancreatic cancer
• Measurable and/or nonmeasurable disease
• No endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer
• No macroscopic residual disease post-resection as the only site of disease
• No clinically significant ascites
• No known brain metastases
• * Patients with neurologic signs or symptoms must undergo brain imaging studies AND studies must be negative for disease
• Zubrod performance status 0-1
• ANC ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Leukocytes ≥ 3,000/mcL
• Total bilirubin normal
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fasting serum glucose \< 120 mg/dL or below the ULN
• * Patients with diabetes mellitus who meet this criterion must be on a stable dietary or therapeutic regimen for this condition
• INR ≤ 1.5 and PTT ≤ 5 seconds above ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing to submit previously collected tumor tissue specimens
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12
• No active acute or chronic infections requiring antibiotics
• No significant ongoing cardiac problems, including any of the following:
• * Myocardial infarction within the past 6 months
• * Uncontrolled hypertension
• * Unstable angina
• * Uncontrolled arrhythmia
• * Congestive heart failure
• No known HIV infection
• No other prior malignancy, except for the following:
• * Adequately treated basal cell or squamous cell skin cancer
• * Carcinoma in situ of the cervix
• * Adequately treated stage I or II cancer from which the patient is currently in complete remission
• * Any other cancer from which the patient has been disease-free for 5 years
• At least 14 days since prior surgery
• At least 28 days since prior radiotherapy for palliation to metastatic sites
• * Patient must have other untreated metastatic sites that would qualify them for this protocol
• At least 6 months since prior adjuvant chemotherapy
• No prior chemotherapy, hormonal therapy, immunotherapy, or chemoradiotherapy for advanced or locally advanced pancreatic cancer, including drugs that target either EGFR or IGFR
• No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer
• No prior gemcitabine hydrochloride
• No prior chimerized or murine monoclonal antibody therapy
• No concurrent CYP3A4 inducers including, but not limited to, any of the following:
• * Rifampicin
• * Rifabutin
• * Rifapentine
• * Phenytoin
• * Carbamazepine
• * Phenobarbital
• * Hypericum perforatum (St. John's wort)
• No concurrent CYP3A4 inhibitors including, but not limited to, any of the following:
• * Atazanavir
• * Clarithromycin
• * Indinavir
• * Itraconazole
• * Ketoconazole
• * Nefazodone
• * Nelfinavir
• * Ritonavir
• * Saquinavir
• * Telithromycin
• * Troleandomycin
• * Voriconazole
• Concurrent prophylactic low-dose coumadin or low molecular weight heparin allowed provided coagulation criteria are met
• Full-dose anticoagulation allowed provided coagulation criteria are met and are under strict control and monitoring