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Chemotherapy
Combined Therapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Theodore S. Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Histologically confirmed localized pancreatic adenocarcinoma; borderline/potentially resectable or locally advanced
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the time of death, up to approximately 6 years
Awards & highlights
Study Summary
This trial is testing to see if the combination of these interventions can effectively treat pancreatic tumors.
Who is the study for?
This trial is for adults over 18 with localized pancreatic adenocarcinoma that's potentially resectable or advanced. Participants must have stable blood pressure, normal organ/marrow function, and an ECOG status of 0-1. Women should use contraception; those pregnant or breastfeeding are excluded. People can't join if they've had certain allergic reactions, severe infections like TB, HIV/AIDS, uncontrolled health issues, recent major surgery without recovery, prior treatments for their tumor or live vaccines within a month.Check my eligibility
What is being tested?
The study tests a combination treatment for pancreatic cancer including FOLFIRINOX (a mix of four drugs), Losartan (a blood pressure medication), Nivolumab (an immunotherapy drug), radiation therapy and surgery to see how well they work together in treating the tumor.See study design
What are the potential side effects?
Possible side effects include reactions to the chemotherapy drugs such as nausea, fatigue, low blood counts leading to increased infection risk; high blood pressure from Losartan; immune-related effects from Nivolumab like inflammation in organs; and typical risks associated with radiation therapy and surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My pancreatic cancer is confirmed and may be operable or advanced but not spread.
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I have been on a stable dose of dexamethasone (2 mg or less) for at least 7 days.
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I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the time of death, up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the time of death, up to approximately 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with R0 resection
Secondary outcome measures
Number of participants with treatment related serious adverse events
Overall survival
Pathologic complete response
+1 moreSide effects data
From 2017 Phase 2 trial • 32 Patients • NCT0183979982%
fatigue
82%
diarrhea
76%
nausea
59%
vomiting
59%
neutropenia
41%
neuropathy
35%
mucositis
35%
dehydration
35%
Mouth Sores
29%
decreased wbc
29%
fever
29%
gas
29%
abdominal pain
29%
hypokalemia
24%
Fever
24%
constipation
24%
hyperglycemia
18%
Insomnia
18%
decreased plt
18%
decreased neutrophils
18%
Nausea
18%
Vomiting
18%
Diarrhea
18%
rash
18%
anorexia
18%
weight loss
18%
UTI
18%
Decreased Platlets
12%
hypotension
12%
Dizziness
12%
hypoalbuminemia
12%
Decreased Appetite
12%
Abdominal pain
12%
decrease wbc
12%
anemia
12%
dysgeusia
12%
Alopecia
12%
Anxiety
12%
peripheral neuropathy
12%
Depression
6%
ratiation dermatitis
6%
abdominal cramping
6%
Ear Bleed -L-ear
6%
increased Ast
6%
hypersensitivity reaction
6%
Muscle twitching
6%
loose stools/intermittent
6%
decreased appetite
6%
paronychia
6%
elevated ALK Phos
6%
Runny nose
6%
protein malnutrition
6%
Viral Syndrome
6%
GI Bleed
6%
Syncope
6%
hepatic infection (SAE)
6%
Non-neutropenic fever
6%
Dehydration
6%
Thrombocytopenia
6%
increased abd distention
6%
CMV
6%
thrombocytopenia
6%
headache
6%
dry skin
6%
skin infection port
6%
abd/cramping/pain
6%
hiccoughs
6%
gout
6%
Lightheadeness
6%
night sweats
6%
flatulance
6%
Thick feeling tongue
6%
Cold Sensitivity
6%
Nasal Congestion
6%
Tunnel Vision
6%
Chest Pressure/Spasm
6%
Gastric Ulcer
6%
Neutropenia
6%
Urinary Incontinence
6%
hypomagnesium
6%
Myalgia
6%
Dyspepsia
6%
Loose bowel movement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 2
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:SurExperimental Treatment5 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion
Losartan will be administered orally as a tablet to be taken by the patient at home every day
SBRT should be administered 2-6 weeks after completing chemotherapy
Participants will receive nivolumab during SBRT
All participants will undergo an attempt at definitive surgical resection following SBRT
Group II: FOLFIRINOX+Losartan:SBRT+Losartan:SurgeryExperimental Treatment4 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion
Losartan will be administered orally as a tablet to be taken by the patient at home every day
SBRT should be administered 2-6 weeks after completing chemotherapy
All participants will undergo an attempt at definitive surgical resection following SBRT
Group III: FOLFIRINOX x 8 : SBRT + Nivolumab : SurgeryExperimental Treatment4 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion
SBRT should be administered 2-6 weeks after completing chemotherapy
Participants will receive nivolumab during SBRT
All participants will undergo an attempt at definitive surgical resection following SBRT
Group IV: FOLFIRINOX: SBRT: SurgeryActive Control3 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion
SBRT should be administered 2-6 weeks after completing chemotherapy
All participants will undergo an attempt at definitive surgical resection following SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRINOX
2013
Completed Phase 3
~790
Losartan
FDA approved
Nivolumab
FDA approved
SBRT
2014
Completed Phase 2
~1060
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,277 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,864 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I am allergic to certain chemotherapy drugs or losartan.I had major surgery less than 4 weeks ago and haven't fully recovered.My pancreatic cancer is confirmed and may be operable or advanced but not spread.I am not currently on ACE or ARB therapy for high blood pressure or kidney protection.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.Your blood pressure is higher than 100 mm Hg when the study starts.I have been on a stable dose of dexamethasone (2 mg or less) for at least 7 days.You have a positive test for hepatitis B or hepatitis C, showing that you have an ongoing infection.You have had a serious allergic reaction to any monoclonal antibody in the past.My organ and bone marrow functions are normal.I have or had lung inflammation not caused by an infection.You have an autoimmune disease that is not on the approved list.I do not have uncontrolled seizures, significant brain disorders, or severe mental health issues.I have an active tuberculosis infection.I am fully active and can carry on all my pre-disease activities without restriction.I have received treatments like chemotherapy for my pancreatic tumor.I have issues with my digestive system that affect how I absorb food.I am not taking cimetidine, as it can affect my cancer treatment.I have a bleeding disorder that is not under control.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have not received a live vaccine in the last 30 days.
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:Sur
- Group 2: FOLFIRINOX x 8 : SBRT + Nivolumab : Surgery
- Group 3: FOLFIRINOX: SBRT: Surgery
- Group 4: FOLFIRINOX+Losartan:SBRT+Losartan:Surgery
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects have been associated with FOLFIRINOX usage?
"FOLFIRINOX is believed to be moderately safe, as evidenced by its score of 2. That being said, there isn't any proof that it can effectively treat the targeted condition at this time."
Answered by AI
What therapeutic purposes is FOLFIRINOX most commonly used for?
"FOLFIRINOX is widely employed to treat metastatic gastroesophageal junction adenocarcinoma. It has also been utilized successfully in cases of metastatic gastric adenocarcinoma, renal cell carcinoma, and complete resection."
Answered by AI
In what exact venues is this experiment taking place?
"This trial is being conducted across a variety of medical institutions, such as Beth Israel Deaconess Medical Center in Aurora, Massachusetts General Hospital in Newton and Brigham and Women's Hospital in Houston. There are 10 locations running this clinical study overall."
Answered by AI
Are any more participants being sought for this research endeavor?
"The clinicaltrials.gov records show that this trial, which was initially posted on August 10th 2018 and last updated September 7th 2022, is no longer actively recruiting candidates. However, there are over 1400 other medical studies seeking participants currently."
Answered by AI
Is there a cap on the number of participants in this clinical trial?
"As of the last update on September 7th 2022, new participants are no longer being accepted. The study was originally published August 10th 2018. Currently, 697 medical trials related to malignant neoplasm of pancreas and an additional 746 studies for FOLFIRINOX are actively recruiting patients."
Answered by AI
What other empirical experiments have been conducted regarding FOLFIRINOX?
"At the current moment, 746 clinical trials are underway related to FOLFIRINOX. Of these studies, 84 have advanced to Phase 3 of research. The majority of examinations for this therapy are being conducted in Zurich, BE though 40759 other sites also provide access to such tests."
Answered by AI
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