Gemcitabine Hydrochloride and Erlotinib Hydrochloride as Second Line Therapy in Treating Patients with Locally Recurrent or Metastatic Pancreatic Cancer That Cannot Be Removed by Surgery

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent
• Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease
• Measureable disease
• Progressive disease or intolerable toxicities during or after treatment with first-line chemotherapy and have not received further second-line chemotherapy; patients treated with prior chemo-radiation to the primary pancreatic tumor, for which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
• Life expectancy of >= 2 months
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Hemoglobin (Hb) >= 9.0 g/dL (transfusion independent)
• Platelet count >= 100 x 10^9/L
• Serum creatinine =< 1.5 x upper limit of normal (ULN)
• Total bilirubin =< 1.5 x ULN
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN
• International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Note: a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Women of child-bearing potential must have a negative pregnancy test at screening

Exclusion Criteria

• Radiation within 4 weeks of study enrollment; radiotherapy not permitted while on study; exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions
• Investigational compound within 4 weeks of enrollment or who are planning to receive other investigational agents while participating in this study
• Chemotherapy, biologics, immunotherapy, vaccine, cytokine therapy within 4 weeks prior to enrollment
• Presence of untreated and/or symptomatic central nervous system (CNS) metastasis
• Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, chronic pulmonary disease or active uncontrolled infection)
• Known diagnosis of human immunodeficiency virus (HIV) infection
• Presence of any other active or suspected acute or chronic uncontrolled infection or known symptomatic active hepatitis B or C
• Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
• History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, cervical cancer in situ, localized biopsy-proven prostate cancer, or stage I colon cancer
• Surgery within 3 weeks prior to enrollment
• Patients taking Coumadin, other agents containing warfarin, rivaroxaban, or dabigatran; (exception: low dose Coumadin [1 mg or less daily] administered prophylactically for maintenance of in-dwelling lines or ports is allowed)
• Patients taking any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
• Pregnant or nursing
• History of non-compliance