Modified Chemotherapy Alternated with Biweekly Gemcitabine plus Nab-Paclitaxel for the Treatment of Stage IV Pancreatic Cancer

Inclusion Criteria

• Histologically and/or cytologically confirmed pancreatic adenocarcinoma
• Stage IV disease. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data
• Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received prior neoadjuvant or adjuvant chemotherapy, tumor recurrence must have occurred more than 6 months after completing the last dose of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• At least 18 years of age
• Evidence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Tumors within a previously irradiated field will be designated as “nontarget” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy
• Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male and female patients must agree to use effective barrier contraception during the period of therapy
• Absolute neutrophil count (ANC) >= 1500/uL
• Platelet count >= 100,000/uL
• Hemoglobin >= 9.0 g/dL
• Total bilirubin =< 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 5 X ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 X ULN
• Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage
• Creatinine < 1.5 x institutional ULN or calculated creatinine clearance >= 50 mL/min as estimated using the Cockcroft-Gault formula
• Partial thromboplastin time (PTT) < 1.2 x ULN and international normalized ratio (INR) =< 1.5 x ULN, if not receiving anticoagulation therapy. For patients receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use
• Subject must have no clinically significant abnormalities in urinalysis results (obtained =< 14 days prior to starting cycle 1 day 1)
• Ability to understand the nature of this study protocol and give written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

• Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
• Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
• Presence of central nervous system metastases
• Life expectancy < 12 weeks
• Pregnancy (positive pregnancy test) or lactation
• Pre-existing sensory neuropathy > grade 1
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
• Major surgery without complete recovery in the past 4 weeks prior to screening
• Prior malignancy except for adequately treated basal 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 form of cancer from which the patient has been disease-free for 5 years
• Concurrent active infection
• Patient with uncontrolled and/ or active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
• Patient who has a history of allergy or hypersensitivity to any of the study drugs
• Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study