Clinical Trial: NCT04682158 - My Cancer Genome

NCT04682158

Description:

This phase II trial studies the side effects and best dose of propranolol when administered concurrently with SOC neoadjuvant CRT in patients with esophageal carcinoma, with a safety lead-in and dose expansion cohort. Patients who are already on β-blockers will receive standard of care CRT and will be considered separately as a single arm prospective cohort

Related Conditions:

Esophageal Adenocarcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04682158

Trial Eligibility

Document

Title

Brief Title: Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
Official Title: Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study

Clinical Trial IDs

ORG STUDY ID: I 630420
NCT ID: NCT04682158

Conditions

Esophageal Adenocarcinoma

Interventions

Drug	Synonyms	Arms
Carboplatin	(SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O'']platinum, Blastocarb, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Ribocarbo	Chemoradiation Therapy - Group I
Propranolol	2-Propanol-1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy) Hydrochloride, 318-98-9, Inderal, Innopran XL	Chemoradiation Therapy plus Propanolol
Paclitaxel	33069-62-4, 5Beta,20-epoxy-1,2alpha, Anzatax, Bristaxol, Praxel, Taxol	Chemoradiation Therapy - Group I

Purpose

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in
      combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal
      cancer.

      SECONDARY OBJECTIVE:

      I. To estimate overall survival (OS) and pathologic response rate in patients that undergo
      surgery.

Trial Arms

Name	Type	Description	Interventions
Chemoradiation Therapy - Group I	Active Comparator	Patients receiving beta-blockers undergo radiation therapy in the form of IMRT or 3D CRT over 23-28 fractions for 5 days per week (Monday-Friday) for 5 weeks, and receive paclitaxel IV QW and carboplatin IV QW for 5 weeks in the absence of disease progression or unacceptable toxicity.	Carboplatin Paclitaxel
Chemoradiation Therapy - Group II	Active Comparator	Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity.
Chemoradiation Therapy plus Propanolol	Experimental	Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-6 weeks while receiving CRT in the absence of disease progression or unacceptable toxicity.	Propranolol

Eligibility Criteria

        Inclusion Criteria:

          -  Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal
             adenocarcinoma

          -  Have an ECOG performance status of 0-1

          -  Have the ability to swallow and retain oral medication (Note: Placement of an enteric
             feeding tube after the patient has signed informed consent will not make them
             ineligible to participate in the study - liquid formula propranolol will be made
             available).

          -  Participants of child-bearing potential must have a negative pregnancy test at study
             entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier
             method of birth control; abstinence) prior to study entry. - Should a woman become
             pregnant or suspect she is pregnant while she or her partner is participating in this
             study, she should inform her treating physician immediately.

          -  Participant must understand the investigational nature of this study and sign an
             Independent Ethics Committee/Institutional Review Board approved written informed
             consent form prior to receiving any study related procedure.

        Exclusion Criteria:

          -  Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable
             angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade
             III or IV), hypotension ( systolic blood pressure <100 mmHg), severe asthma or COPD,
             uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 or fasting plasma glucose
             > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's
             syndrome, untreated pheochromocytoma, current calcium channel blocker use
             (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and
             amiodarone. Patients with pacemakers will be excluded

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric
             illness/social situations that would limit compliance with study requirements, cardiac
             arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of <50 beats
             per minute or 1st/ 2nd /3rd degree heart block)

          -  Pregnant or nursing female participants,

          -  Unwilling or unable to follow protocol requirements

          -  Any condition which in the Investigator's opinion deems the participant an unsuitable
             candidate to receive study drug

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Occurrence of Adverse Events
Time Frame:	Up to 5 years
Safety Issue:
Description:	To determine the safety and efficacy of the combination of propranolol plus chemoradiation

Secondary Outcome Measures

Measure:	Overall Survival
Time Frame:	Up to 5 years
Safety Issue:
Description:	will be assessed by chart review of date of last follow-up or date of death

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Roswell Park Cancer Institute

Last Updated

June 14, 2021

Clinical Trials /

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma