Capecitabine, Bevacizumab, and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
In brief
Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may kill more tumor cells. This phase II trial is studying how well giving capecitabine and bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Key facts
- Study ID
- NCT00114179
- Run by
- National Cancer Institute (NCI)
- People needed
- 82
- Starts
- 2005-01-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2020-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed adenocarcinoma of the pancreas
- Locally advanced disease
- Unresectable disease
- All malignant disease must be encompassable within a single irradiation field
- Radiographically assessable disease
- Patients with biliary or gastroduodenal obstruction are eligible provided drainage or surgical bypass was performed prior to initiation of study treatment
- No evidence of gastric outlet obstruction
- No evidence of duodenal invasion on CT scan
- No evidence of metastatic disease in the major viscera
- No peritoneal seeding or ascites
- Performance status - Zubrod 0-1
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No evidence of bleeding diathesis
- ALT < 3 times upper limit of normal
- Bilirubin < 2.0 mg/dL
- INR ≤ 1.5
- No evidence of coagulopathy
- Creatinine clearance > 50 mL/min
- Urine protein < 1,000 mg by 24-hour urine collection (for patients with proteinuria ≥ 1+ by dipstick or urinalysis OR urine protein:creatinine ratio ≥ 1.0)
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No arterial thromboembolic events within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
Where it is running
- Radiation Therapy Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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