NCT00107341

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

A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Determine the confirmed tumor response rate in patients with unresectable, metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with bortezomib, paclitaxel, and carboplatin. Secondary * Determine the time to tumor progression, overall survival, and duration of response in patients treated with this regimen. * Determine the adverse events in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17 months.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	bortezomib
DRUG	carboplatin
DRUG	paclitaxel

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-02-01
• Completion: 2008-05-01
• First posted: 2005-04-06
• Last updated: 2016-12-13