BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology… (NCT02022033) | Clinical Trial Compass
CompletedPhase 2
BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
United States25 participantsStarted 2014-02-01
Plain-language summary
The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a better regimen in the adjuvant setting for patients with resected pancreatic cancer. This protocol will obtain preliminary data on safety and disease-free and overall survival following administration of FOLFOX-A for patients with resected pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
* Interval between definitive tumor-related surgery and registration between 21-70 days.
* Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
* Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
* Preexisting neuropathy \< grade 1 (per CTCAE).
* ECOG performance status 0 or 1.
* Age ≥ 18
* Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause of lack of menses \>12 months) do not need to have a pregnancy test, please document status.
* Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
* Required Initial Laboratory Values:
* Neutrophils ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 x ULN
* AST (SGOT) \& ALT (SGPT) ≤ 2.5 x ULN
* Alkaline pho…