Clinical trial NCT02022033: BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Official title: BrUOG 295:Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Adjuvant
Pancreas
Resected
Invasive adenocarcinoma
adenosquamous cancer
Intraductal papillary mucinous neoplasm
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: See summary above

Eligibility criteria: 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 phosphatases \< 2.5x ULN
* Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6 weeks of registration on study. Patients can have PET/MRI of the chest/abdomen instead.

Exclusion Criteria:

* Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
* Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed
* Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
* Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study
* No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible. This must be documented.

Primary outcomes:
measure: Feasibility of Adjuvant FOLFOX-A
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Disease-free Survival
timeFrame: Through study completion, an average of 3 years.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Roxanne Wood
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: BrUOG
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
References: