Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00052507|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: bortezomib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052507
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Princess Margaret Hospital at University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Amit M. Oza, MD||Princess Margaret Hospital, Canada|