BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: FOLFOXA

Detailed Description

See summary above

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02179
      • Southcoast Centers for Cancer Care
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
2. Metastatic advanced disease.
3. No prior chemotherapy for pancreatic cancer
4. 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.
5. 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.
6. ECOG performance status 0 or 1.
7. Age ≥ 18
8. 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 >12 months) do not need to have a pregnancy test, please document status.
9. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. Documentation of this being discussed required.

10. 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 ≤ 1.25 x ULN
    • AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST&ALT < 5xULN)
    • Alkaline phosphatase < 2.5xULN, unless bone metastasis is present and in the absence of liver metastasis

Exclusion Criteria:

1. Patients with known brain metastases
2. Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
3. Preexisting neuropathy
4. 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 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.

6. 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.

7. Patients with sepsis or pneumonitis. 8. 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOLFOXA; 1 cycle = 14 days 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.)	Drug: FOLFOXA; Other Names: 1 cycle = 14 days; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.	Every 3 months for up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen	Every 3 months for up to 5 years.

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Lifespan; SouthCoast Medical Group; Memorial hospital
• Investigators: Principal Investigator: Howard Safran, MD, BrUOG

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: pancreatic cancer; metastatic pancreatic cancer; metastatic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin
• Other Study ID Numbers: BrUOG 292