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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Registration Number
NCT00052507
Lead Sponsor
University Health Network, Toronto
Brief Summary

RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.

Detailed Description

OBJECTIVES:

* Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.

* Determine the toxicity of this drug in these patients.

* Determine the time to progression and response duration in patients treated with this drug.

* Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Cancer Care Ontario-Hamilton Regional Cancer Centre

🇨🇦

Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

🇨🇦

London, Ontario, Canada

Ottawa Regional Cancer Centre

🇨🇦

Ottawa, Ontario, Canada

Princess Margaret Hospital at University Health Network

🇨🇦

Toronto, Ontario, Canada

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