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Chemotherapy
Propranolol + Pembrolizumab + Chemotherapy for Esophageal Cancer
Phase 2
Recruiting
Led By Sarbajit Mukherjee
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment initiation until death from any cause, assessed up to 2 years
Awards & highlights
Study Summary
This trial tests if adding propranolol to pembrolizumab and chemo can help treat esophageal/gastroesophageal junction cancer. Propranolol is a beta-blocker that may help reduce stress hormones which can impede the immune system's ability to fight cancer.
Who is the study for?
Adults with unresectable locally advanced or metastatic esophageal/gastroesophageal junction adenocarcinoma, who haven't had treatment for it yet. They should be in good physical condition (ECOG 0-1), have adequate organ function, and no prior PD-1/PD-L1 therapy within the last year. Participants must not have HER2-positive cancer, active autoimmune diseases requiring immunosuppression, uncontrolled illnesses, or be on beta-blockers already.Check my eligibility
What is being tested?
The trial is testing if adding propranolol to pembrolizumab (an immune system booster) and standard chemotherapy mFOLFOX can improve treatment response in patients with certain types of esophageal cancer. Propranolol is a beta-blocker that might help reduce stress effects on the immune system.See study design
What are the potential side effects?
Possible side effects include heart-related issues due to propranolol; infusion reactions from pembrolizumab; and nausea, fatigue, low blood counts from chemotherapy. Each patient may experience side effects differently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment initiation until death from any cause, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment initiation until death from any cause, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Incidence of toxicities and adverse events
ORR
Overall survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mFOLFOX6, pembrolizumab, propranolol)Experimental Treatment9 Interventions
Patients receive mFOLFOX6 (leucovorin IV, oxaliplatin IV, and fluorouracil IV), pembrolizumab IV, and propranolol PO on study. Patients also undergo tumor biopsy during screening and CT scans and collection of blood samples during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1700
Pembrolizumab
2017
Completed Phase 2
~2010
Biopsy
2014
Completed Phase 4
~1090
Fluorouracil
2014
Completed Phase 3
~11540
Propranolol Hydrochloride
2021
Completed Phase 3
~130
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,767 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,659 Total Patients Enrolled
Sarbajit MukherjeePrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking beta-blockers for my condition.I am living with HIV.I am 18 years old or older.I am fully active or can carry out light work.I have untreated brain or spinal cord metastases.My cancer is HER2-positive.I have an active autoimmune disease or a history of transplantation.I am on a low dose of steroids, not more than 10 mg of prednisone daily.I do not have any other cancers needing treatment through the bloodstream.I can provide a biopsy sample taken within the last year or am willing to have one before treatment starts.My kidneys are functioning well enough (creatinine clearance rate is at least 30 mL/min).I have not received any live vaccines in the last 30 days.I have advanced esophageal cancer and haven't started treatment, except possibly PD-1/PD-L1 therapy over a year ago.I have active Hepatitis B or C.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation.I have had lung inflammation that needed treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I cannot take beta-blockers due to certain health issues like severe asthma, very low blood pressure, or uncontrolled heart failure.I can swallow pills or have a feeding tube for medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mFOLFOX6, pembrolizumab, propranolol)
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of adverse effects can be expected from mFOLFOX6, pembrolizumab and propranolol usage?
"Our team at Power gave Treatment (mFOLFOX6, pembrolizumab, propranolol) a score of 2 due to the fact that there is limited safety evidence and no existing efficacy data which can be drawn from Phase 2 trials."
Answered by AI
Is enrollment for this clinical trial still open?
"According to clinicaltrials.gov, the aforementioned study is no longer recruiting patients as of December 7th 2022. The trial was first announced on 30th December 2020 and has since seen its last edit. Although this particular research project is not currently enrolling participants, there are 964 other trials searching for volunteers at present."
Answered by AI
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