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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center Pfizer |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00323011 |
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin (LV) affect blood-clotting factors. A second purpose of this study is to find out what effects the drug dalteparin has on clotting factors in the blood in patients receiving the drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin to chemotherapy may benefit patients with colorectal cancer by preventing blood clots
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Fragmin, 5-Flurouracil, Folinic Acid, irinotecan, bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Efficacy Study |
Official Title: | A Randomized Pilot Study of the Activation of the Hemostatic Pathway by FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
USCNorris Hospital | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Syma Iqbal, MD | University of Southern California |
Responsible Party: | University of Southern California ( Syma Iqbal, MD ) |
Study ID Numbers: | 3C-05-2 |
Study First Received: | May 5, 2006 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00323011 |
Health Authority: | United States: Institutional Review Board |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Leucovorin Bevacizumab Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Dalteparin Gastrointestinal Neoplasms Colorectal Neoplasms |
Vitamin B Complex Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Vitamins Therapeutic Uses Micronutrients Angiogenesis Modulating Agents Growth Inhibitors |