Phase
Condition
Digestive System Neoplasms
Metastatic Cancer
Treatment
Folfirinox alternating with Gemcitabine-nab-Paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically and/or cytologically confirmed pancreatic adenocarcinoma.
Stage IV disease. The definitive diagnosis of metastatic pancreatic adenocarcinomawill be made by integrating the histopathological data within the context of theclinical and radiographic data.
Subject must have received no prior therapy for the treatment of metastatic disease.Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizerduring and up to 4 weeks after radiation therapy is allowed. If a subject receivedprior neoadjuvant or adjuvant chemotherapy, tumor recurrence must have occurred morethan 6 months after completing the last dose of chemotherapy.
ECOG performance status of 0-1.
At least 18 years of age.
Evidence of measurable or non-measurable but evaluable disease as defined by theResponse Evaluation Criteria in Solid Tumors (RECIST 1.1). Tumors within apreviously irradiated field will be designated as "nontarget" lesions unlessprogression is documented or a biopsy is obtained to confirm persistence at least 90days following completion of radiotherapy.
Female patients of childbearing potential must have a negative pregnancy test (serumor urine) prior to enrollment. Male and female patients must agree to use effectivebarrier contraception during the period of therapy.
Adequate bone marrow function:
8a. ANC ≥ 1500/uL 8b.platelet count ≥ 100,000/uL 8c. hemoglobin ≥ 9.0 g/dL 9. Adequate hepatic function: 9a. Total bilirubin ≤ 1.5 X ULN 9b. AST (SGOT) ≤ 5 X ULN 9c. ALT (SGPT) ≤ 5 X ULN Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
Adequate renal function, Creatinine < 1.5x institutional ULN or calculatedcreatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
Partial thromboplastin time (PTT) < 1.2 x ULN and INR ≤ 1.5 x ULN, if not receivinganticoagulation therapy. For patients receiving anticoagulants, exceptions to thesecoagulation parameters are allowed if they are within the intended or expected rangefor their therapeutic use.
Subject must have no clinically significant abnormalities in urinalysis results (obtained ≤ 14 days prior to starting Cycle 1 Day 1).
Ability to understand the nature of this study protocol and give written informedconsent. 14. Willingness and ability to comply with scheduled visits, treatmentplans, laboratory tests, and other study procedures.
Exclusion
Exclusion Criteria:
Patients who meet any one of the following criteria will be excluded from this study.
Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, isletcell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenalcarcinomas, distal bile duct and ampullary carcinomas.
Any condition including the presence of laboratory abnormalities, which, in theopinion of the investigator places the subject at unacceptable risk if he/she wereto participate in the study.
Presence of central nervous system metastases.
Life expectancy < 12 weeks.
Pregnancy (positive pregnancy test) or lactation.
Pre-existing sensory neuropathy > grade 1.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomaticcoronary artery disease and cardiac arrhythmias not well controlled with medication)or myocardial infarction within the last 6 months.
Major surgery without complete recovery in the past 4 weeks prior to screening.
Prior malignancy except for adequately treated basal cell skin cancer, in situcervical cancer, adequately treated Stage I or II cancer from which the patient iscurrently in complete remission, or any other form of cancer from which the patienthas been disease-free for 5 years.
Concurrent active infection.
Patient with uncontrolled and/ or active infection with HIV, Hepatitis B orHepatitis C.
Patient who has a history of allergy or hypersensitivity to any of the study drugs.
Patients with a history of interstitial lung disease, history of slowly progressivedyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonaryfibrosis, pulmonary hypersensitivity pneumonitis.
Any significant medical condition, laboratory abnormality, or psychiatric illnessthat would prevent the subject from participating in the study.
Study Design
Study Description
Connect with a study center
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey 08690
United StatesSite Not Available
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City, New Jersey 07302
United StatesSite Not Available
RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
Livingston, New Jersey 07039
United StatesSite Not Available
Monmouth Medical Center
Long Branch, New Jersey 07740
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesSite Not Available
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesSite Not Available
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerset, New Jersey 08873
United StatesSite Not Available
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