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

NCT02578732 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG 318
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Pancreatic Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

FOLFOXA

EXPERIMENTAL

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, 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 infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) * It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment * Antiemetics will be administered as per standard institutional policy.

Drug: FOLFOXA

Interventions

FOLFOXA DRUG

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, 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 infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) * It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment * Antiemetics will be administered as per standard institutional policy.

Also known as: FOLFOXA is a combination treatment including: Abraxane, Oxaliplatin, Leucovorin

FOLFOXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator

Study Sites (1)

Rhode Island Hospital and The Miriam Hospital

Providence, Rhode Island, 02903/02906, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Howard Safran, MD
• Organization: Brown University Oncology Research Group

BrUOG@BROWN.EDU

401-863-300

Study Officials

• Howard Safran, MD

  BrUOG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: July 12, 2016
• Primary Completion: December 18, 2019
• Study Completion: March 16, 2022
• Last Updated: May 6, 2023
• Results First Posted: August 13, 2021

Record last verified: 2023-05

Locations

US (1)