Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Metastatic Pancreatic Cancer, Abraxane, Gemcitabine Read More

Inclusion Criteria:

• Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.

• Male or non-pregnant and non-lactating female, and age greater or equal to 18.

  • If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test beta-human chorionic gonadotropin (B-hCG) documented within 72 hours of the first administration of study drug.
  • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator.
• Patient must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a patient received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.

• Patient has the following blood counts at baseline

  • Absolute neutrophil count (ANC) equal or greater to 1.5 x 10^9/L;
  • Platelets equal or greater to 100 x 10^9/L
  • Hemoglobin equal or greater to 9 g/dL.
  • Patient has the following blood chemistry levels at baseline:
  • Aspartate aminotransferase (SGOT), Alanine aminotransferase (SGPT) equal or less than 2.5 x upper limit of normal range (ULN) is allowed
  • Bilirubin less than or equal to ULN
  • Serum creatinine within normal limits or calculated clearance equal or greater to 60 mL/min/1.73M^2 patients with serum creatinine levels above the institutional normal value
• Patient has no clinically significant abnormalities in urinalysis results
• Patient has acceptable coagulation status as indicated by a prothrombin time (PT) within normal limits (plus or minus 15%) and partial thromboplastin time (PTT) within normal limits (plus or minus 15%).
• Patient has a Karnofsky performance status (KPS) greater or equal to 70 (Eastern Cooperative Oncology Group [ECOG] PS 0-1).
• Patient has one or more metastatic tumors measurable by computed tomography (CT) scan.
• Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

• Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart).
• Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT).
• Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Patient has known infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C.
• Patient has undergone major surgery, other than diagnostic surgery i.e.-- done to obtain a biopsy for diagnosis without removal of an organ), with 4 weeks prior to Day 1 of treatment in this study.
• Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).
• Patient has a history of allergy or hypersensitivity to the study drug.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Patient is unwilling or unable to comply with study procedures.
• Patient is enrolled in any other clinical protocol or investigational trial.