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Sponsored by: |
Oncozyme Pharma Inc. |
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Information provided by: | Oncozyme Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00809796 |
The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of colon cancer metastasis in subjects receiving standard therapy.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: pentamidine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Clinical Study Using Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Folinic Acid, 5-Fluorouracil, or Capecitabine and Oxaliplatin Chemotherapy as Second-Line and/or Third-Line Treatment |
Estimated Enrollment: | 15 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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single arm: Experimental
Use of pentamidine in second and/or third line metastatic colon cancer
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Drug: pentamidine
one dose of 4 mg/kg to two dose of 4 mg/kg with possibility of escalated to two dose of 6 mg/kg with or without standard chemotherapy.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 |
Principal Investigator: | Petr Kavan, MD, Ph.D. | Jewish General Hospital/McGill University |
Responsible Party: | Oncozyme Pharma Inc. ( Dr. Terry Chow/President ) |
Study ID Numbers: | OP-103 |
Study First Received: | December 15, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809796 |
Health Authority: | Canada: Canadian Institutes of Health Research |
Capecitabine Digestive System Neoplasms Clotrimazole Gastrointestinal Diseases Miconazole Colonic Diseases Tioconazole Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Pentamidine Colonic Neoplasms Colorectal Neoplasms |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Neoplasms |
Neoplasms by Site Therapeutic Uses Antifungal Agents Pharmacologic Actions |