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Sponsors and Collaborators: |
Georgetown University Sanofi-Aventis |
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Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00881504 |
This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection.
The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer.
In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested.
Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.
Condition | Intervention | Phase |
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Biliary Tract Cancer |
Drug: Modified FOLFOX6 and Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma |
Estimated Enrollment: | 24 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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FOLFOX6 and Bevacizumab: Experimental
Treatment with modified FOLFOX6 and Bevacizumab
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Drug: Modified FOLFOX6 and Bevacizumab
Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks
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This is a single-center, open labeled, single-arm study in patients with previously untreated unresectable biliary tract cancer. This trial will follow a Simon's two-stage optimal design. For the first stage, 9 patients will be accrued. If none of the 9 patients have controlled disease with mFOLFOX6 in combination with bevacizumab, the combination will be rejected and the trial stopped. However, if at least 1 patient of the 9 (11%) respond to treatment in the first stage, then an additional 15 patients will be entered into the second stage, for a total of 24 patients in the phase II study. If 3 (13%) or more patients respond to therapy, then the combination will be considered for further investigation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Ley, MSN | 202-687-6533 | leyl@georgetown.edu |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Lisa Ley, MSN 202-687-6533 leyl@georgetown.edu | |
Principal Investigator: John L Marshall, MD |
Principal Investigator: | John L Marshall, MD | Georgetown University |
Responsible Party: | Georgetown University Medical Center ( John L. Marshall, MD ) |
Study ID Numbers: | OX-07-006, 2007-411 |
Study First Received: | April 13, 2009 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00881504 History of Changes |
Health Authority: | United States: Institutional Review Board |
Biliary Oxaliplatin Bevacizumab |
Disulfiram Biliary Tract Neoplasms Digestive System Neoplasms Leucovorin Bevacizumab Folinic Acid Angiogenesis Inhibitors |
Carcinoma Oxaliplatin Digestive System Diseases Biliary Tract Diseases Fluorouracil Gastrointestinal Neoplasms Biliary Tract Cancer |
Biliary Tract Neoplasms Digestive System Neoplasms Antineoplastic Agents Growth Substances Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Biliary Tract Diseases Angiogenesis Modulating Agents Growth Inhibitors |