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

NCT02080221 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG 292
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

metastatic pancreatic cancer; pancreatic cancer; metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen

  Every 3 months for up to 5 years.

Study Arms (1)

FOLFOXA

EXPERIMENTAL

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

Interventions

FOLFOXA DRUG

Also known as: 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.)

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 cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
• Metastatic advanced disease.
• 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 \>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. Documentation of this being discussed required.
• 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)

You may not qualify if:

• Patients with known brain metastases
• Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
• Preexisting neuropathy
• 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.
• \. 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 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.
• \. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or uncontrolled) required at registration.

Sponsors & Collaborators

• Brown University: lead
• Lifespan: collaborator
• SouthCoast Medical Group: collaborator
• Memorial hospital: collaborator

Study Sites (2)

Southcoast centers for cancer care

Fairhaven, Massachusetts, 02179, United States

Location

Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport)

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel; Oxaliplatin; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; 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

4018633000

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: March 3, 2014
• First Posted: March 6, 2014
• Study Start: August 1, 2014
• Primary Completion: January 9, 2020
• Study Completion: March 16, 2022
• Last Updated: August 1, 2022
• Results First Posted: August 13, 2021

Record last verified: 2022-07

Locations

US (2)