Clinical trial · Interventional
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
NCT00142480CI-TRIAL-00032664completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Gallbladder Adenocarcinoma | Gallbladder Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine, Oxaliplatin, Bevacizumab
- description
- 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.
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Bevacizumab
- Procedure: Radiation therapy
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.