Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
Completed · Phase 2
Conditions studied: Biliary Tract Cancer, Gallbladder Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT00142480
- Run by
- Massachusetts General Hospital
- People needed
- 8
- Starts
- 2004-12-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2018-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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