Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma Non-resectable
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.
Sites / Locations
- Western Regional Medical Center
Arms of the Study
Arm 1
Experimental
Gemcitabine and nab-Paclitaxel
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