BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

Study Overview

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.

See summary above

Pancreatic Cancer

DRUG: FOLFOXA

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 2013-11-27	Results First Submitted 2021-03-11	Last Update Submitted that met QC Criteria 2022-05-12
First Submitted that Met QC Criteria 2013-12-20	Results First Submitted that Met QC Criteria 2021-08-12	Last Update Posted (ACTUAL) 2022-06-01
First Posted (ACTUAL) 2013-12-27	Results First Posted 2021-09-08	Last Verified 2022-05

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 Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusio	DRUG: FOLFOXA Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusio

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFOXA

Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusio

DRUG: FOLFOXA

Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusio

Primary Outcome Measures	Measure Description	Time Frame
Feasibility of Adjuvant FOLFOX-A	Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.	Up to 24 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Disease-free Survival	To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A.	Through study completion, an average of 3 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:

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.

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.

Collaborators and Investigators

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

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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Resources

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Clinical Trial Record