Bevacizumab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Undergoing Surgery For Locally Advanced Pancreatic Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT00602602
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • fluorouracil — DRUG
  • gemcitabine hydrochloride — DRUG
  • oxaliplatin — DRUG
  • immunohistochemistry staining method — OTHER
  • laboratory biomarker analysis — OTHER
  • conventional surgery — PROCEDURE
  • endoscopic biopsy — PROCEDURE
  • laparoscopy — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: 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. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with combination chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: The phase II trial is studying the side effects and how well giving bevacizumab together with gemcitabine, oxaliplatin, fluorouracil, and radiation therapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.

Key Dates

First listed
Jan 28, 2008
Start date
Mar 31, 2007
Status verified
Apr 2020
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GemOx and Bev, then chemoradiation, then surgery
    Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated. One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention

Primary Outcome Measure

Response rate pre-radiation chemotherapy and bevacizumab and after 5-6 weeks of concurrent chemoradiotherapy and bevacizumab [ Time Frame: after 6-12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-4283-

Find similar trials in Philadelphia, PA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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