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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00673673 |
Purpose
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 |
|---|---|---|
|
Gastroesophageal Cancer Gastric Cancer |
Drug: FOLFOX Drug: bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
FOLFOX in combination with bevacizumab
|
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
Other Names:
Drug: bevacizumab
bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Other Name: Avastin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Medical Oncology & Hematology PC | Recruiting |
| Hamden, Connecticut, United States | |
| Contact: Jeremy Kortmansky, M.D. 203-407-8002 jkortmansky@mohmd.com | |
| Contact: Dawn Solada 203-407-8002 dsolada@mohmd.com | |
| 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 |
More Information
| Responsible Party: | Jill Lacy, M.D., Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00673673 History of Changes |
| Other Study ID Numbers: | 0710003118 |
| Study First Received: | May 5, 2008 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil Bevacizumab Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |