Overview

FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated with the ability to administer at least 10 cycles of therapy. Investigators therefore will evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
howard safran
Collaborators:
Brown University
Rhode Island Hospital
Treatments:
Leucovorin
Oxaliplatin
Criteria
Inclusion Criteria:

- Pathologically or cytologically confirmed pancreatic ductal adenocarcinoma. Patients
with pathology or cytology showing carcinoma of pancreas or adenosquamous of the
pancreas are also eligible.

- Locally advanced pancreatic cancer, including patients defined by Callery19 as
"unresectable" and "borderline resectable" are eligible:

- Measurable disease as per RECIST 1.1

- No prior chemotherapy for pancreatic cancer.

- No major surgery within 3 weeks of the start of study treatment. Patients must have
recovered from the side effects of any major surgery at the start of study treatment.
For questions on if a surgery is deemed "major," definition by surgeon can be used for
clarification. Laparoscopy and central venous catheter placement are not considered
major surgery.

- 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.

- 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 or lack of menses >24 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 28 days prior to treatment, during treatment and for three months
after completing treatment (men are to use contraception for six months post last dose
of drug). Documentation of this being discussed required.

- Required Initial Laboratory Values:

- Neutrophils ≥ 1,500/mm3

- Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving
platelet transfusions within 7 days prior to laboratory sample)

- Hemoglobin > 9.0g/dL

- 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 phosphatase < 2.5xULN. (Patients with elevated alkaline phosphatase,
total bilirubin, AST and ALT, who have subsequently undergone biliary stenting
and their liver tests are improving, do not need to wait for their alkaline
phosphatase to become < 2.5x ULN if their total bilirubin, AST and ALT have
improved to within required study levels and the alkaline phosphatase is
decreasing.)

Exclusion Criteria:

- Patients with metastatic disease

- Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion
would put the patient at risk if re-exposed

- Preexisting neuropathy is not allowed from any cause.

- 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

- Patients with unstable biliary stents or with plastic stents. Information on type of
stent is required at registration.

- Patients with active infection or fever (patients on antibiotics for infection or
patients getting over a cold or seasonal virus are not excluded), or known historical
or active infection with HIV, hepatitis B, or hepatitis C.

- Patients with active sepsis or pneumonitis.

- Patients with a history of interstitial lung disease, history of slowly progressive
dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,
pulmonary hypersensitivity pneumonitis or multiple allergies that in the
investigator's opinion would put the patient at an increased risk.

- Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or
uncontrolled) required at registration.