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Topoisomerase I inhibitors

Irinotecan for Gastroesophageal Junction Adenocarcinoma

Phase 2
Waitlist Available
Led By Haeseong Park, M.D., MPH
Research Sponsored by Washington University School of Medicine
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 up to 30 months from completion of treatment (estimated to be 36 months)
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a combination of drugs for people with stomach or gastro-esophageal junction cancer who have not responded to first-line chemotherapy.

Eligible Conditions
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months from completion of treatment (estimated to be 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months from completion of treatment (estimated to be 36 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Best overall response (BOR)
Clinical benefit rate (CBR)
Objective response rate (ORR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Irinotecan plus ramucirumabExperimental Treatment4 Interventions
-Patients will receive ramucirumab intravenously on an outpatient basis at a dose of 8 mg/kg over the course of 60 minutes on Day 1 of each 14-day cycle. They will then receive irinotecan intravenously at a dose of 180 mg/m2 over the course of 90 minutes on Day 1 of each 14-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Ramucirumab
2017
Completed Phase 3
~5050
Blood for angiome profiling
2017
Completed Phase 2
~40
Blood for cfDNA
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,669 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,018 Total Patients Enrolled
Haeseong Park, M.D., MPHPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any avaliable positions for test subjects in this experiment?

"This particular study has ceased recruiting new patients, however, there are 1,320 other trials involving adenocarcinoma and Irinotecan that are still looking for participants."

Answered by AI

Is this trial taking place in a lot of hospitals across Canada?

"There are 4 main locations for this trial: Washington University School of Medicine in Saint Louis, H. Lee Moffitt Cancer Center and Research Institute, Inc. in Tampa, UT Southwestern Medical Center in Dallas. Additionally, there are other centres located elsewhere."

Answered by AI

What are the primary functions of Irinotecan?

"In addition to colorectal carcinoma, Irinotecan is commonly used to treat ovarian cancer, sarcoma, and adenocarcinoma."

Answered by AI

How does this study compare to others that have used Irinotecan?

"There are currently 320 clinical trials testing irinotecan. Of these, 60 have progressed to Phase 3 and are thus in the late stages of development. Though many of these studies originate from Melbourne, Victoria, there are 11,699 total locations running tests for this medication."

Answered by AI

How many volunteers are helping with this research?

"This study is not accepting patients at the moment. It was originally posted on November 1st, 2017 and was last edited on June 22nd, 2022. If you are looking for other studies, there are currently 1000 trials involving adenocarcinoma and 320 with Irinotecan that are enrolling patients right now."

Answered by AI

Are there long-term repercussions to taking Irinotecan?

"While there is some data supporting safety, as this is only a Phase 2 trial, Power rates the safety of Irinotecan at a 2."

Answered by AI
~5 spots leftby Apr 2025