nab-pac+cis+gem in pts w previously untreated metastatic pda

Conditions: Stage IV Pancreatic Cancer

Summary: the primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (pda).

this is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. an individual cycle of therapy will be defined as days 1 and 8 every 21 days. multiple cycles may be administered until the patient is withdrawn from therapy. overall response rates as well as individual categories of response (complete response-cr, partial response-pr, stable disease-sd and progressive disease-pd) will be determined using recist 1.1. time-to-event endpoints, including progression free survival (pfs) and os (overall survival) will be assessed using the kaplan-meier method. evaluation of stable disease at 9 weeks will also be assessed. toxicity (adverse events) will be recorded using the nci ctcae (v4.0, may 2009).

Eligibility criteria:
inclusion criteria: * age \>18 years of age; male or female. * histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. * capable of providing informed consent and complying with trial procedures. * karnofsky performance status (kps) of \>/=70%. * life expectancy \>/=12 weeks. * measurable tumor lesions according to recist 1.1 criteria. * women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. women of child bearing potential must have a negative serum or urine pregnancy test at the screening visit and be non-lactating. both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study. exclusion criteria: * patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. prior treatments in the adjuvant setting with gemcitabine and/or 5-fu or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. * palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment. * exposure to any investigational agent within 4 weeks prior to initiation of study treatment. * evidence of central nervous system (cns) metastasis (negative imaging study, if clinically indicated, within 4 weeks of screening visit). * history of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for \>/= 5 years. * laboratory values: screening serum creatinine \> upper limits of normal (uln); total bilirubin \> uln: alanine aminotransferase (alt) and ast \>/= 2.5 uln or \>/= 5.0 x uln if liver metastases are present; absolute neutrophil count \ 1.5 x uln unless on therapeutic doses of warfarin. * current, serious, clinically significant cardiac arrhythmias as determined by the investigator. * history of hiv infection. * active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. * major surgery within 4 weeks prior to initiation of study treatment. any condition that might interfere with the patient's participation in the study or in the evaluation of the study results. * any condition that is unstable and could jeopardize the patient's participation in the study.

Keywords: pancreatic cancer pancreatic adenocarcinoma stage iv pancreatic cancer pancreas pancreatic