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| Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052507 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer |
| Study Start Date: | January 2003 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
Contacts and Locations| Canada, Ontario | |
| 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 |
More Information
| Study ID Numbers: | CDR0000258488, PMH-PHL-012, NCI-5890 |
| Study First Received: | January 24, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00052507 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
|
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Bortezomib Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Protease Inhibitors Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Bortezomib Enzyme Inhibitors Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Protease Inhibitors Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |