CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
bortezomib +1 moredrug
Likely dose
Bortezomib IV (dose not specified in criteria); irinotecan IV (dose not specified in criteria)AI-extracted
Key inclusion· 5
  • Histologically or cytologically confirmed adenocarcinoma of GE junction or stomach, unresectable/beyond surgical resection
  • Measurable disease: ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • ECOG performance status ≤2 (Karnofsky ≥60%)
  • Life expectancy >6 weeks
Key exclusion· 6
  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to entry or unrecovered adverse events from prior therapy
  • Concurrent investigational agents, radiation therapy, or chemotherapy; prior photodynamic therapy within 4 weeks unless for esophageal obstruction relief
  • Known brain metastases
  • Uncontrolled intercurrent illness: ongoing/active infection, symptomatic CHF, unstable angina, cardiac arrhythmia, psychiatric illness/social situations limiting compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00061932
NCT00061932Phase 2Completed

A Phase II Study of PS-341 Alone or in Combination With Irinotecan in Patients With Adenocarcinoma of the Gastroesophageal Junction (GEJ) or Stomach

National Cancer Institute (NCI)·interventional·Posted Jun 6, 2003·Updated Feb 2, 2021

In Brief

A Phase 2 clinical trial evaluating bortezomib and irinotecan for Adenocarcinoma of the Gastroesophageal Junction and 7 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

Study Details

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2003
Enrollment StartApr 1, 2003
Primary CompletionDec 1, 2009
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 23.1 years ago

Interventions

bortezomibdrug

Given IV

irinotecandrug

Given IV