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

Inclusion Criteria:

* 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