Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and
oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and
paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients
with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as
fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and
paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill
more tumor cells. It is not yet known whether combination chemotherapy is more effective than
gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before
surgery in treating pancreatic cancer.
Phase
Phase 2
Funding Agency/Sponsor
National Cooperative Group
Disease
Pancreatic, Liver, and Related Cancers
Enrollment Eligibility
Inclusion Criteria:
- Patients must have histologically or cytologically proven pancreatic adenocarcinoma;
histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
- Patients must have measurable disease in the pancreas; computed tomography (CT) scans
or magnetic resonance imaging (MRIs) used to assess measurable disease must have been
completed within 28 days prior to registration; all disease must be assessed and
documented on the baseline tumor assessment form
- Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT
or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is
NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of
the chest, abdomen, and pelvis, where resectable is defined as:
- No involvement of the celiac artery, common hepatic artery, and superior
mesenteric artery (and, if present, replaced right hepatic artery)
- No involvement, or < 180° interface between tumor and vessel wall, of the portal
vein and/or superior mesenteric vein; and patent portal vein/splenic vein
confluence
- No evidence of metastatic disease
- Note: for tumors of the body and tail of the pancreas, involvement of the splenic
artery and vein of any degree is considered resectable disease
- CT scans or MRIs used to assess disease at baseline must be submitted for central
review
- Patients must have surgical consult to verify patient is a surgical candidate within
21 days prior to registration
- Patients must not have received prior surgery, radiation therapy, chemotherapy,
targeted therapy, or any investigational therapy for pancreatic cancer
- Patients must have a Zubrod performance status of 0-1
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN
- Serum albumin >= 3 g/dL
- Serum creatinine =< IULN within 14 days prior to registration
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements will NOT be eligible
- No prior malignancy is allowed except for adequately treated basal (or squamous cell)
skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or
other cancer for which the patient has been disease and treatment-free for two years
- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method for up to 3 months after the
final administered dose of chemotherapy; a woman is considered to be of "reproductive
potential" if she has had menses at any time in the preceding 12 consecutive months;
in addition to routine contraceptive methods, "effective contraception" also includes
heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect
of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or
bilateral tubal ligation; however, if at any point a previously celibate patient
chooses to become heterosexually active during the time period for use of
contraceptive measures, he/she is responsible for beginning contraceptive measures
- Sites must seek additional patient consent for the future use of specimens
- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines
- As a part of the OPEN registration process the treating institution's identity is
provided in order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system