Clinical Trials Directory

Trials / Completed

CompletedNCT00051987

Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
175 (planned)
Sponsor
Millennium Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGVELCADE TM (bortezomib) for Injection, or PS-341

Timeline

Start date
2002-12-01
Primary completion
2004-03-01
First posted
2003-01-22
Last updated
2008-02-11

Locations

22 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00051987. Inclusion in this directory is not an endorsement.

Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma (NCT00051987) · Clinical Trials Directory