Clinical trial NCT00617708 (phase 1/phase 2, status: completed)
Conditions: stage iv pancreatic cancer
ICD codes: C25.3
Drugs: erlotinib hydrochloride, gemcitabine hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        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