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Sponsors and Collaborators: |
Stanford University AstraZeneca |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00532909 |
To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with becavizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: Vandetanib Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Vandetanib Combined With Capecitabine, Oxaliplatin and Bevacizumab for the First-Line Treatment of Metastatic Colorectal Cancer |
Estimated Enrollment: | 33 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Provision of signed informed consent.
Absolute Neutrophil Count (ANC) >=1.5 x 109/L (>=1500/mm3) Platelets (PLT) >=100 x 109/L (>=100,000/mm3) Hemoglobin (Hgb) >=9 g/dL Serum creatinine <=1.5 x ULN Serum bilirubin <=1.5 x ULN Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <=2.5 x ULN (<=5 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests.
Negative or trace for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein <=500 mg and measured creatinine clearance (CrCl) >=50 mL/min from a 24-hour urine collection
Life expectancy >12 weeks Exclusion Criteria: Laboratory results:
Serum bilirubin >1.5 x the upper limit of reference range (ULRR) Serum creatinine >1.5 x ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula.) Potassium, <4.0 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or >5x ULRR if judged by the investigator to be related to liver metastases
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Heidi Kaiser 650-724-0079 hkaiser@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Branimir I Sikic | |
Sub-Investigator: George Albert Fisher M.D. Ph.D. | |
Sub-Investigator: Elwyn Cabebe MD |
Principal Investigator: | Branimir I Sikic | Stanford University |
Study ID Numbers: | COR0006, 97132, COR0006, NCT00532909 |
Study First Received: | September 20, 2007 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00532909 |
Health Authority: | United States: Food and Drug Administration; USA:Institutional Review Board |
Oxaliplatin Capecitabine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Bevacizumab Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |