BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
278
BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
1 other identifier
interventional
35
1 country
3
Brief Summary
The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer. The experimental part of the study is combining these drugs together in FOLFOX-A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2012
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
April 11, 2016
CompletedFebruary 17, 2020
February 1, 2020
1.8 years
November 26, 2012
May 6, 2015
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.
MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.
For up to 30 days post completing drug, an expected average of 6 months
Secondary Outcomes (1)
Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.
pre-drug until disease progression, whichever comes first, for an expected average of 6 months
Study Arms (3)
Dose level 1
EXPERIMENTALAbraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Dose level 2/ MTD
EXPERIMENTALAbraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Dose level 3
EXPERIMENTALAbraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Interventions
Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Eligibility Criteria
You may qualify if:
- Pathologically confirmed pancreatic ductal adenocarcinoma.
- Metastatic or locally advanced disease.
- No prior treatment for pancreatic cancer
- Radiographically measurable disease.
- No major surgery within 4 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. Laparoscopy and central venous catheter placement are not considered major surgery.
- 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
- Preexisting neuropathy \> grade 1.
- 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 years of age.
- 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.
- Required Initial Laboratory Values:
- Neutrophils ≥ 1,500/μl
- Platelet count ≥ 100,000/μl
- Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
- +2 more criteria
You may not qualify if:
- Patients with known brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- Lifespancollaborator
- Rhode Island Hospitalcollaborator
- Memorial Hospital of Rhode Islandcollaborator
Study Sites (3)
Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
Rhode Island Hospital (including Newport and East Greenwich locations)
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Helena Lau
- Organization
- Brown Oncology Research Group
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Safran, MD
Brown University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 26, 2012
First Posted
December 6, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2014
Study Completion
August 1, 2015
Last Updated
February 17, 2020
Results First Posted
April 11, 2016
Record last verified: 2020-02