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Sponsors and Collaborators: |
Yale University Genentech |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00673673 |
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.
Condition | Intervention | Phase |
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Gastroesophageal Cancer Gastric Cancer |
Drug: FOLFOX Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
FOLFOX in combination with bevacizumab
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Drug: FOLFOX
Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
Drug: bevacizumab
bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX 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:
Contact: Lois Ravage-Mass, RN | 203-785-4991 | lois.ravage-mass@yale.edu |
Contact: Lynne Lamb, RN | 203-737-2562 | lynne.lamb@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Principal Investigator: Jill Lacy, M.D. |
Principal Investigator: | Jill Lacy, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Jill Lacy, M.D., Principal Investigator ) |
Study ID Numbers: | 0710003118 |
Study First Received: | May 5, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00673673 |
Health Authority: | United States: Institutional Review Board |
Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Leucovorin Gastrointestinal Neoplasms Stomach cancer Bevacizumab |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |