Status:
TERMINATED
Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect...
Detailed Description
* The combination of all three drugs and radiation treatment has never been given to people before, therefore, we are going to add just one additional drug at a time for safety reasons. * The first gr...
Eligibility Criteria
Inclusion
- Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy
- Disease is measurable by CT scan
- Age \>= to 18 years
- Life expectancy of 4 months or longer
- ANC \>/= 1,500mm/cm3
- Hemoglobin \>/= 9g/dl
- Platelet count \>/= 100,000/cm3
- Total bilirubin \</= 2 times control
- SGOT/SGPT \</= 2.5 times upper limit of normal
- Serum creatinine \< 2mg/dl
- No evidence of metastatic disease by laparoscopy
Exclusion
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications
- No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years
- Patients with pre-existing peripheral neuropathy of grade 2 or greater
- Pregnant or lactating women
- Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study
- Blood pressure of \>150/100 mmHg
- Unstable angina
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- Urine protein creatinine ratio \> or = to 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
- Serious, non-healing wound, ulcer, or bone fracture
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00307723
Start Date
May 1 2006
End Date
July 1 2009
Last Update
August 10 2009
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