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Anti-tumor antibiotic
Combination Chemotherapy for Stomach and Esophageal Cancer
Phase 2
Recruiting
Led By Nataliya Uboha, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmed locally advanced or metastatic EGA
Known PDL1 CPS status prior to treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for people with advanced esophageal and gastric cancer. Thenew combination is hoped to be better tolerated than current first-line chemotherapy combinations.
Who is the study for?
This trial is for adults with advanced Esophageal and Gastric Adenocarcinoma who haven't had systemic therapy for it. They should be relatively fit (ECOG 0-2), have certain blood counts, organ function within set limits, known HER2/PDL1 status, measurable disease by RECIST v1.1 standards, and not pregnant or breastfeeding. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs (5-FU, oxaliplatin, nal-IRI) with immunotherapy agents (pembrolizumab or nivolumab; trastuzumab added if HER2-positive). It's an open-label phase II trial aiming to see if this mix is safer and more effective than current treatments for these cancers.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used, nerve damage from oxaliplatin leading to numbness or tingling in hands/feet, diarrhea from irinotecan, heart problems due to trastuzumab especially in those with pre-existing conditions; immune-related issues like inflammation of organs can occur due to pembrolizumab/nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread and was confirmed by a lab test.
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I know my PDL1 status before starting treatment.
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My white blood cell count is healthy without needing medication to boost it.
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I can take care of myself and am up and about more than half of my waking hours.
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I haven't received any systemic therapy for my advanced disease.
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My kidney function is within the required range.
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I know my cancer's HER2 status before starting treatment.
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My liver enzyme AST levels are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Cohort 1: Objective Response Rate (ORR)
Cohort 3: Objective Response Rate (ORR)
Cohorts 2 and 4: Incidence of Adverse Events
Secondary outcome measures
Cohorts 1 and 3: Incidence of Adverse Events
Cohorts 2 and 4: Overall Response Rate
Disease Control Rate (DCR)
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: HER2 PositiveExperimental Treatment5 Interventions
Participants in Cohort 4 (HER2-positive) will be treated with nal-IRI (50 mg/m^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m^2 over 46 hrs), oxaliplatin (60 mg/m^2), and pembrolizumab (400 mg). Each cycle is 42 days. Participants will receive chemotherapy and trastuzumab treatments on day 1, 15, and 29 of each cycle. Pembrolizumab will be given on day 1 of each cycle.
Group II: Cohort 3: HER2 NegativeExperimental Treatment4 Interventions
Participants in Cohort 3 (HER2-negative) will be treated with nal-IRI (50 mg/m^2 - intravenously over 90 min), 5-FU (2400 mg/m^2 over 46 hrs), oxaliplatin (60 mg/m^2), and nivolumab. (240 mg). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle
Group III: Cohort 2: HER2 PositiveExperimental Treatment4 Interventions
Participants in Cohort 2 (HER2-positive) will be treated with nal-IRI (50 mg/m^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m^2 over 46 hrs), and oxaliplatin (60 mg/m^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.
Group IV: Cohort 1: HER2 NegativeExperimental Treatment3 Interventions
Participants in Cohort 1 (HER2-negative) will be treated with nal-IRI (50 mg/m^2 - intravenously over 90 min), 5-FU (2400 mg/m^2 over 46 hrs), and oxaliplatin (60 mg/m^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Oxaliplatin
2011
Completed Phase 4
~2560
5-FU
2014
Completed Phase 3
~3420
Trastuzumab
2014
Completed Phase 4
~5190
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,494 Total Patients Enrolled
IpsenIndustry Sponsor
346 Previous Clinical Trials
73,248 Total Patients Enrolled
Nataliya Uboha, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery in the last 28 days or minor surgery in the last 14 days, except for a biopsy or port placement.I haven't needed treatment for an autoimmune disease in the last 2 years, except for certain conditions like vitiligo or type I diabetes.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My hemoglobin level is at least 8 g/dL, or I've had a transfusion to reach this.My cancer is advanced or has spread and was confirmed by a lab test.I know my PDL1 status before starting treatment.I haven't needed treatment for another cancer, except for certain low-risk types, in the last 2 years.I have not had radiotherapy in the week before starting the study treatment.My blood clotting time is normal or near normal, or controlled if I'm on blood thinners.I haven't had immunotherapy for EGA before and can safely receive drugs like nivolumab or pembrolizumab.I have a known DPD deficiency.My blood clotting time is normal or near normal, even if I'm on blood thinners.My white blood cell count is healthy without needing medication to boost it.I can take care of myself and am up and about more than half of my waking hours.I have severe heart failure, irregular heartbeats, or high blood pressure that isn't controlled.I haven't received any systemic therapy for my advanced disease.My bilirubin levels are within the normal range.I understand and can follow the study's procedures.I am allergic to certain chemotherapy drugs like 5-FU or oxaliplatin.I am not currently on any experimental drugs but may be in a non-drug study or getting prescreened for other trials.My kidney function is within the required range.My recent tests show my organs are functioning well.My brain metastases are stable, and I haven't used steroids in the last 7 days.I haven't had a severe heart attack, unstable chest pain, or stroke in the last 6 months.I am capable of becoming pregnant and have a recent negative pregnancy test.I have been diagnosed with HIV.I know my cancer's HER2 status before starting treatment.My cancer returned 6 months or more after finishing all previous treatments.I am currently on medication for an infection.My liver enzyme AST levels are within the required range.I agree to use birth control or abstain from sex during and 30 days after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: HER2 Positive
- Group 2: Cohort 4: HER2 Positive
- Group 3: Cohort 3: HER2 Negative
- Group 4: Cohort 1: HER2 Negative
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA evaluated 5-FU for safety and efficacy?
"5-FU has not been proven effective yet, but there is some evidence that it is safe. Therefore, it received a score of 2."
Answered by AI
Are there any open vacancies for participants in this experiment?
"This trial, which was first posted on July 13th 2020 and updated November 14th 2020 is still recruiting patients according to the latest information from clinicaltrials.gov"
Answered by AI
What benefit has 5-FU been shown to have for patients?
"5-FU, which is most often used to treat small cell lung cancer (sclc), can also be effective at managing rectal carcinoma, colorectal carcinoma, and ovarian cancer."
Answered by AI
What are the primary goals of this research?
"This clinical trial's primary goal is to evaluate Objective Response Rate (ORR) in Cohort 1 over the course of up to one year. Additionally, this study will also collect data on Secondary outcomes including Incidence of Adverse Events, Progression Free Survival (PFS), and Overall Response Rate in Cohorts 2 and 4."
Answered by AI
What do we know about 5-FU from previous research?
"At present, there are 820 ongoing clinical trials studying 5-FU. Of these, 237 are in Phase 3. Most of the 5-FU clinical trials are based in Seattle, Washington; however, there are 37990 locations around the world where such trials are taking place."
Answered by AI
How many people total are participating in this trial?
"That is accurate. If you refer to the information on clinicaltrials.gov, you will see that this trial has an open recruitment and was first posted on 7/13/2020. The study is looking for 52 patients at 1 sites."
Answered by AI
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