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Sponsors and Collaborators: |
Mt. Sinai Medical Center, Miami Abraxis BioScience Inc. |
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Information provided by: | Mt. Sinai Medical Center, Miami |
ClinicalTrials.gov Identifier: | NCT00625573 |
This is an open-label, phase II study to evaluate the efficacy and safety of Abraxane in combination with Capecitabine in patients with metastatic colorectal cancer in the second or third line
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Abraxane |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01) |
Estimated Enrollment: | 29 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Inclusion Criteria
Required Screening Laboratory Criteria:
Exclusion Criteria
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required Screening Laboratory Criteria:
Exclusion Criteria:
Contact: Joseph Pizzolato, MD | 305-535-3300 | jpizzolato@aptiumoncology.com |
Contact: Kenia Caballero, RN | 305-674-2625 | kcaballe@msmc.com |
United States, Florida | |
Mount Sinai Medical Center | Recruiting |
Miami Beach, Florida, United States, 33140 | |
Contact: Joseph Pizzoloato, MD 305-535-3300 jpizzolato@aptiumoncology.com | |
Contact: Kenia Caballero, RN 305-674-2625 kcaballe@msmc.com |
Principal Investigator: | Joseph Pizzolato, MD | Mt. Sinai Medical Center Miami Beach Florida |
Responsible Party: | Mt. Sinai Medical Center ( Joseph Pizzolato, M.D. ) |
Study ID Numbers: | COL-01 |
Study First Received: | February 19, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00625573 |
Health Authority: | United States: Institutional Review Board |
Colon Cancer Abraxis Oncology Abraxane Phase II |
Colorectal Mt. Sinai Medical Center CCOP |
Capecitabine Digestive System Diseases Digestive System Neoplasms Paclitaxel Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |