A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
Trial Information
A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
- 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 group of participants (3-4) who enroll on the study will receive 5-FU,
radiation therapy with the added drug oxaliplatin, this is called Regimen level 1. If
these participants have few or easily manageable side effects, then another group of
participants will be enrolled and will receive 5-FU, radiation, oxaliplatin with the
addition of bevacizumab this is called Regimen level 2.
- The combination of study drugs and radiation will last about 6 weeks, this 6 week
period is called a cycle 1.
- Regimen Level 1 will receive the following: oxaliplatin intravenously on days 1, 8, 15,
22, 29, and 36; 5-FU infused by a continuous infusion on days 1-5, 8-12, 15-19, 22-26,
29-33, and 36-38; radiation therapy Monday-Friday to complete on day 38.
- Regimen Level 2 will receive the following; bevacizumab intravenously on days 1, 15,
and 29; oxaliplatin intravenously on days 1, 8, 15, 22, 29 and 36; 5-FU infused by
continuous infusion days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy
Monday-Friday to complete on day day 38.
- The following are tests and procedures that will be performed during cycle 1: physical
examination; blood work, urine sample. perfusion CT scan on day 12 (for those
participants enrolled at Massachusetts General Hospital).
- At the end of cycle 1, CT scans will be performed to evaluate the participants disease
status before they receive combination gemcitabine and bevacizumab. If the scans show
the tumor has reduced in size and can be surgically removed, then surgery will be
scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after
the surgery. If the scans show the tumor can not be removed, the patient will receive
the gemcitabine/bevacizumab combination about 4 weeks after completing cycle 1.
- Cycles 2-5 consist of: gemcitabine given intravenously on days 1, 8, and 15 every 28
days; bevacizumab given intravenously on days 1 and 15 every 28 days. During cycles 2-5
the following tests and procedures will be performed: physical examination including
vital signs on day 1 and 15 of each cycle; blood work on days 1, 8 and 15 of each
cycle; a urine sample on day 1 of each cycle; CT scans will be done every 2 cycles.
- It will take about 7 months to complete the study treatment (longer for those who have
surgery after Cycle 1).
Inclusion Criteria:
- 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
- SGOT/SGPT
- Serum creatinine < 2mg/dl
- No evidence of metastatic disease by laparoscopy
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Lawrence S. Blaszkowsky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
05-233
NCT ID:
NCT00307723
Start Date:
May 2006
Completion Date:
July 2009
Related Keywords:
- Pancreatic Cancer
- Pancreatic Ductal Adenocarcinoma
- EBRT
- advanced pancreatic cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
- Carcinoma, Ductal, Breast
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