BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic Cancer, Adjuvant, Pancreas, Resected, Invasive adenocarcinoma, adenosquamous cancer, Intraductal papillary mucinous neoplasm
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FOLFOXA
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Memorial Hospital
Providence, Rhode Island, United States
Status: Not yet recruiting
Contact: Kristen Mitchell - 4018633000 - Kristen_Mitchell@brown.edu
Rhode Island Hospital (East Greenwich and Newport Hospital)
Providence, Rhode Island, United States
Status: Recruiting
Contact: Kristen Mitchell - 401-863-3000 - Kristen_Mitchell@brown.edu
The Miriam Hospital
Providence, Rhode Island, United States
Status: Recruiting
Contact: Kristen Mitchell - 401-863-3000 - kristen_Mitchell@brown.edu
Start Date
February 2014
Completion Date
June 2017
Sponsors
howard safran
Source
Brown University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page