A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma

Millennium Pharmaceuticals, Inc.22 sites in 1 country175 target enrollmentDecember 2002

ConditionsColorectal Carcinoma

DrugsVELCADE TM (bortezomib) for Injection, or PS-341

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal Carcinoma
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 175
Locations: 22
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate how tumors in patients with colorectal carcinoma respond to treatment with VELCADE alone versus VELCADE given with irinotecan, and also to see what effects (good and bad) it has on you and your cancer.

Detailed Description

In this study, patients with colorectal cancer that is no longer responding to standard medical treatment with irinotecan or an irinotecan containing treatment will be randomized to treatment with VELCADE alone or to treatment with VELCADE in combination with irinotecan.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

March 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel