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

Study Overview

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.

See summary above

Locally Advanced Pancreatic Cancer
Pancreatic Cancer

DRUG: FOLFOXA

BrUOG 318

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-15	Results First Submitted 2021-03-11	Last Update Submitted that met QC Criteria 2023-05-03
First Submitted that Met QC Criteria 2015-10-16	Results First Submitted that Met QC Criteria 2021-08-12	Last Update Posted (ACTUAL) 2023-05-06
First Posted (ACTUAL) 2015-10-19	Results First Posted 2021-08-13	Last Verified 2023-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFOXA Schema: 1 cycle = 14 days It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG Abraxane ®: 150mg/m2 IV over 30 minutes, da	DRUG: FOLFOXA Schema: 1 cycle = 14 days It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG Abraxane ®: 150mg/m2 IV over 30 minutes, da

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFOXA

Schema: 1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG** Abraxane ®: 150mg/m2 IV over 30 minutes, da

DRUG: FOLFOXA

Schema: 1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG** Abraxane ®: 150mg/m2 IV over 30 minutes, da

Primary Outcome Measures	Measure Description	Time Frame
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.		From date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival for Patients With Locally Advanced Pancreatic Cancer Treated With FOLFOX-A		During treatment (approximately every 2 weeks for up to 6 months), then approximately every 4 months for for a maximum of 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.)

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Rhode Island Hospital

Investigators

PRINCIPAL_INVESTIGATOR: Howard Safran, MD, BrUOG

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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