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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 bevacizumab 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 Anal, Colon, and Rectal Cancers |
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 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute Neutrophil Count (ANC) >=1.5 x 10^9/L (>=1500/mm^3) Platelets (PLT) >=100 x 10^9/L (>=100,000/mm^3) 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
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
Contact: Heidi Kaiser | (650) 724-0079 | hkaiser@stanford.edu |
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 |
Responsible Party: | Stanford University School of Medicine ( Branimir I Sikic, Principal Investigator ) |
Study ID Numbers: | COR0006, 97132, COR0006, NCT00532909 |
Study First Received: | September 20, 2007 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00532909 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Capecitabine Digestive System Neoplasms Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |