|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital Genentech Sanofi-Synthelabo Hoffmann-La Roche |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00142480 |
Purpose
The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Tract Cancer Gallbladder Adenocarcinoma |
Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab Procedure: Radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer |
| Estimated Enrollment: | 26 |
| Study Start Date: | December 2004 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29; capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of no capecitabine, followed by another 14 days of capecitabine (days 22-35).
Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments.
During this first phase of the study the following tests will be performed weekly: physical exam, vital signs, medical history, blood tests and urine tests.
After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP, blood tests and a physical exam to evaluate the status of the disease.
Phase two of the study is broken up into two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease.
If the patients had tumors removed prior to entering the study, they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of treatment.
Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded (reduced in size) and can now be resected, will have surgery to remove the tumors.
Following surgical recovery (8-10 weeks) they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
If the evaluation tests show that the patients' cancer has remained stable (not gotten worse or better) they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
During the additional 12 weeks of study treatment a physical exam, vital signs, medical history, blood testing and urine testing will be performed once every 3 weeks.
At the end of study treatment the following evaluations will be performed: physical exam, vital signs, blood work, CT scan of the chest and abdomen, MRCP, and tumor measurements by CT scans. These evaluations will be repeated every 3 months thereafter.
Patients will be removed from the study if their disease worsens or there are unacceptable side effects.
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| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Andrew Zhu, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Andrew Zhu, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00142480 History of Changes |
| Other Study ID Numbers: | 04-144 |
| Study First Received: | August 31, 2005 |
| Last Updated: | December 28, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
locally advanced biliary adenocarcinoma unresectable biliary adenocarcinoma gallbladder adenocarcinoma capecitabine |
oxaliplatin bevacizumab Biliary tract adenocarcinoma |
|
Adenocarcinoma Gallbladder Neoplasms Biliary Tract Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Oxaliplatin Capecitabine Bevacizumab |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |