Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Official Title
-----------------
A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: nab-Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma. Patient has one or more radiographically measurable tumor. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT). Age ≥ 18 years. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study. ECOG performance status 0 - 2 and an expected survival of at least 3 months. 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 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. 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: Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting. Previous use of any chemotherapy or radiation therapy for metastatic disease. 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). Other significant active or chronic infection. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia. Pregnant or nursing females. 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. Major surgery, other than diagnostic surgery within 4 weeks of study entry. Patient requires a legal authorized representative for consenting.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine and nab-Paclitaxel<br>Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days | Drug: Gemcitabine<br>* Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion<br>* Other names: Gemzar;Drug: nab-Paclitaxel<br>* Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion<br>* Other names: Abraxane;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Based on Toxicity Profile of Adverse Events. | Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival Time | Determine progression free survival time with this regimen | One year |