Overview

This trial is active, not recruiting.

Conditions biliary tract cancer, gallbladder adenocarcinoma
Treatments capecitabine, oxaliplatin, bevacizumab, radiation therapy
Phase phase 2
Target VEGF
Sponsor Massachusetts General Hospital
Collaborator Dana-Farber Cancer Institute
Start date December 2004
End date July 2007
Trial size 26 participants
Trial identifier NCT00142480, 04-144

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
time frame: 3 years

Secondary Outcomes

Measure
To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed locally advanced unresectable biliary tract or gallbladder adenocarcinoma - Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible. - > 4 weeks since time of major surgery - > 2 weeks since time of minor surgery - > 4 weeks since time of major radiotherapy for other malignancy - > 4 weeks since participation in any investigational drug study - > 1 year since treatment for other carcinomas, except cured non-melanoma skin and treated in-situ cervical cancer - 18 years of age or older - ECOG performance status of 0-2 - Life expectancy > 12 weeks - Absolute neutrophil count (ANC) > 1,500/mm3 - Hemoglobin > 9.0 gm/dl - Platelets > 100,000/mm3 - SGOT < 5 x upper limits of normal (ULN) - Total bilirubin < 2.5 mg/dl - Creatinine clearance > 50 ml/min Exclusion Criteria: - Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer - Peripheral neuropathy of grade 2 or greater - Unstable angina - Symptomatic congestive heart failure - Myocardial infarction < 12 months prior to registration - New York Heart Association classification III or IV - Active or uncontrolled infection - Known existing uncontrolled coagulopathy - Malabsorption syndrome or lack of integrity of the upper gastrointestinal (GI) tract - Prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency - Known brain metastases or carcinomatous meningitis - Pregnant or lactating women - Serious, non-healing wound, ulcer, or bone fracture - Evidence of bleeding diathesis or coagulopathy

Additional Information

Official title Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
Principal investigator Andrew Zhu, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.