At a glance
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Ramucirumab Plus Irinotecan in Patients With Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Irinotecan, Ramucirumab, and 2 other interventions for Gastric Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma. Completed, enrolled 40 participants across 4 sites.
Detailed Summary
The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab administered as second line treatment will be tolerated and lead to improved outcomes similar to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have progressed after first line chemotherapy. To the knowledge of the investigators, this regimen has not been previously administered to this patient population, so safety and tolerability will be monitored and reported.
Study Details
Timeline
Interventions
-Irinotecan is commercially available and will be billed to insurance.
-Ramucirumab will be provided free of charge by Eli Lilly and Company.
-Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
-Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment