Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Biliary Tract Neoplasms

Gallbladder Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Biliary Tract Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Bevacizumab

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.

Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).

Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29

Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.

Once daily for 5 days (Monday through Friday) for a total of 28 treatments.

Radiation therapy

Andrew Zhu, MD

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.

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.

Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer	NCT00142480	Biliary Tract C... Gallbladder Ade...	Capecitabine Oxaliplatin Bevacizumab Radiation thera...	18 Years -	Massachusetts General Hospital
Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer	NCT00142480	Biliary Tract C... Gallbladder Ade...	Capecitabine Oxaliplatin Bevacizumab Radiation thera...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for unresectable biliary adenocarcinoma