Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
Condition: Pancreatic Carcinoma Non-resectable; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; nab-Paclitaxel
Intervention description: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion; Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine whether the occurrence of adverse events can be decreased by moving to a
      bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of
      unresectable/metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically-proven unresectable/metastatic pancreatic
             adenocarcinoma.

          2. Patient has one or more radiographically measurable tumor.

          3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).

          4. Age ≥ 18 years.

          5. Patient must have read, understood, and provided written informed consent and HIPAA
             authorization after full explanation of the nature of the study.

          6. ECOG performance status 0 - 2 and an expected survival of at least 3 months.

          7. Acceptable hematological parameters within 2 weeks of commencing study therapy as
             follows:

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

               -  Platelet count ≥ 100 x 10^9/L

               -  Hemoglobin (Hgb) ≥ 9g/dl

          8. Patients with adequate organ function as measured by:

             A. Cardiac: American Heart Association Class I: Patients with cardiac disease but
             without resulting limitation of physical activity. Ordinary physical activity does not
             cause undue fatigue, palpitation, dyspnea, or anginal pain.

             B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.

             C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.

          9. Women must meet one of the following criteria:

               -  Post-menopausal for at least one year

               -  Surgically incapable of child-bearing

               -  Utilizing a reliable form of contraception for the duration of study
                  participation. Women of child-bearing potential must have a negative serum β-HCG
                  within 7 days of study drug administration.

        Exclusion Criteria:

          1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as
             monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.

          2. Previous use of any chemotherapy or radiation therapy for metastatic disease.

          3. Patient has known brain metastases, unless previously treated and well-controlled for
             at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2
             scans at least 4 weeks apart).

          4. Other significant active or chronic infection.

          5. History of active other malignancy excluding basal or squamous cell carcinoma of the
             skin or cervical intraepithelial neoplasia.

          6. Pregnant or nursing females.

          7. Patient has serious medical risk factors involving any of the major organ systems, or
             serious psychiatric disorders, which could compromise the patient's safety or the
             study data integrity.

          8. Major surgery, other than diagnostic surgery within 4 weeks of study entry.

          9. Patient requires a legal authorized representative for consenting.