drugset / Trial / NCT00107341

Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction

NCT00107341 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable, metastatic cancer of the esophagus or gastroesophageal junction.

Timeline

Start
2005-08
Primary completion
2007-02
Completion
2008-05

Outcome

Missed primary endpoint

paper The tumor response rate was lower than that anticipated at 23% (95% confidence interval: 10%, 40%), thereby prompting premature study closure. PMID 18449005 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.2 unknown Intravenous
Subject Carboplatin Small molecule — Intravenous
Subject Paclitaxel Small molecule 175 unknown Intravenous

Indications