5-FU for Stomach Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Wisconsin Carbone Cancer Center, Madison, WIStomach Cancer+1 More5-FU - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Stomach Cancer
  • Esophageal Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: up to 2 years

up to 1 year
Cohort 1: Incidence of Adverse Events
Cohort 1: Objective Response Rate (ORR)
Cohort 2: Incidence of Adverse Events
Cohort 2: Overall Response Rate
Cohort 3: Objective Response Rate (ORR)
Cohorts 1 and 3: Incidence of Adverse Events
Cohorts 2 and 4: Incidence of Adverse Events
Cohorts 2 and 4: Overall Response Rate
Disease Control Rate (DCR)
Progression Free Survival at 12 months
up to 2 years
Progression Free Survival (PFS)
up to 6 months
Progression Free Survival at 6 months

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Cohort 2: HER2 Positive
1 of 4
Cohort 4: HER2 Positive
1 of 4
Cohort 3: HER2 Negative
1 of 4
Cohort 1: HER2 Negative
1 of 4

Experimental Treatment

52 Total Participants · 4 Treatment Groups

Primary Treatment: 5-FU · No Placebo Group · Phase 2

Cohort 2: HER2 PositiveExperimental Group · 4 Interventions: Oxaliplatin, 5-FU, Trastuzumab, Nal-IRI · Intervention Types: Drug, Drug, Drug, Drug
Cohort 4: HER2 PositiveExperimental Group · 5 Interventions: Pembrolizumab, Oxaliplatin, 5-FU, Trastuzumab, Nal-IRI · Intervention Types: Drug, Drug, Drug, Drug, Drug
Cohort 3: HER2 NegativeExperimental Group · 4 Interventions: Oxaliplatin, 5-FU, Nivolumab, Nal-IRI · Intervention Types: Drug, Drug, Drug, Drug
Cohort 1: HER2 NegativeExperimental Group · 3 Interventions: Oxaliplatin, 5-FU, Nal-IRI · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
Trastuzumab
FDA approved
Nivolumab
2014
Completed Phase 3
~4480

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,081 Previous Clinical Trials
2,591,920 Total Patients Enrolled
IpsenIndustry Sponsor
325 Previous Clinical Trials
69,242 Total Patients Enrolled
Nataliya Uboha, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
3 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received any previous treatment for your advanced disease.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.