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

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Brief Title

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

Official Title

A Phase II Study of Gemcitabine, Oxaliplatin and Bevacizumab Followed by 5-Fluorouracil, Oxaliplatin, Bevacizumab and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Brief Summary

      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.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  To describe the toxicity of bevacizumab with gemcitabine and oxaliplatin, when therapy
           is given before chemoradiotherapy, in patients with locally advanced pancreatic cancer.

        -  To describe the toxicity of bevacizumab with oxaliplatin, fluorouracil, and concomitant
           radiotherapy in these patients.

        -  To define progression-free survival, time to progression, and overall survival of
           patients treated with this regimen.

      Second

        -  To determine the percentage of potentially resectable patients who are ultimately able
           to proceed to successful resection.

        -  To determine the relationship between markers of apoptosis in tumor cells (including
           MIF, CREB, HIF-1-alpha expression/polymorphism, and others) and response to therapy.

        -  To define response rates in patients treated with this regimen.

      OUTLINE:

        -  Neoadjuvant therapy: Patients receive gemcitabine IV over 100 minutes and bevacizumab IV
           over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats
           every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable
           toxicity. Between 4-6 weeks after completion of initial therapy, patients undergo
           radiotherapy once daily, 5 days a week, for 5-6 weeks. Beginning within 48 hours after
           initiation of radiotherapy, patients receive fluorouracil IV continuously through
           completion of radiotherapy. Patients also receive concurrent oxaliplatin IV over 2 hours
           on days 1, 15 and 29 and bevacizumab IV on days 1 and 15.

        -  Surgery: Four to six weeks after completion of neoadjuvant therapy, patients undergo
           resection of the tumor. Patients with no evidence of disease progression and who undergo
           successful surgical intervention (i.e., R0 resection) proceed to adjuvant chemotherapy
           within the next 6-10 weeks.

        -  Adjuvant therapy: Patients receive gemcitabine and bevacizumab for 4 courses as in
           neoadjuvant therapy.

      Patients undergo collection of tumor tissue samples at the time of diagnosis, prior to
      treatment by endoscopic ultrasound or laparoscopy, or during surgical resection following
      neoadjuvant therapy. Paraffin-embedded tumor tissue specimens obtained at baseline are
      analyzed by immunohistochemistry to assess tumor vascularity and angiogenic activity. Tumor
      vascularity is assessed via immunostaining of tumor specimens with the pan-endothelial cell
      marker, anti-CD34, for evaluation of tumor blood vessels. Angiogenic activity is assessed by
      analyzing pERK1/2, Ki67, and the pericyte coverage index in tumor specimens. Patients also
      undergo blood collection to determine plasma levels of VEGF at 4 weeks prior to initial
      chemotherapy and bevacizumab, at up to 48 hours prior to chemoradiotherapy and bevacizumab,
      and at up to 48 hours prior to adjuvant chemotherapy and bevacizumab.

      After completion of study therapy, patients are followed every 2 months for the first year,
      and then every 3 months thereafter.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate after 6 and 12 weeks of pre-radiation chemotherapy and bevacizumab and after 5-6 weeks of concurrent chemoradiotherapy and bevacizumab

Secondary Outcome

 Percentage of potentially resectable patients who are able to proceed to successful resection

Condition

Pancreatic Cancer

Intervention

bevacizumab


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

99

Start Date

March 2007


Primary Completion Date

December 2017

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the pancreas

               -  Resectable, marginally resectable, or unresectable disease determined by one of
                  the following:

                    -  Contrast-enhanced helical-CT scan

                    -  Endoscopic ultrasound with biopsy (in patients who do not have metastatic or
                       grossly unresectable disease)

                    -  Dedicated pancreatic MRI

               -  Tumor must be locally advanced or potentially resectable, as determined by one of
                  the following:

                    -  Abutment of the portal or superior mesenteric veins, hepatic or superior
                       mesenteric artery

                    -  Extension to the origin of gastroduodenal artery

                    -  Occlusion of the superior mesenteric vein for < 2 cm

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥
             10 mm by spiral CT

               -  Marker elevation alone not allowed as justification for study entry

          -  Formalin-fixed, paraffin-embedded tumor tissue specimens from prior biopsy or surgical
             resection allowed for correlative studies

          -  No known brain metastases or tumor metastatic to the peritoneum, liver, or other
             organs

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  ANC ≥1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN

          -  Bilirubin < 2.0 mg/dL (≤ 10 mg/dL for patients with biliary obstruction by tumor)

               -  A biliary stent ≥ 9F or biliary bypass is required before treatment if there is
                  biliary obstruction by tumor

          -  Urine protein:creatinine ratio ≤ 1.0

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No significant traumatic injury within the past 28 days

          -  No serious non-healing wounds, ulcers, or bone fractures

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No myocardial infarction, unstable angina, or cerebrovascular accident within the past
             6 months

          -  No NYHA class II-IV congestive heart failure

               -  Class II defined as symptoms of fatigue, dyspnea or other symptoms with ordinary
                  physical activity

          -  No clinically significant peripheral vascular disease

          -  Pre-existing hypertension allowed, provided that the patient is receiving a stable
             antihypertensive regimen and has a blood pressure ≤ 150/100 mm Hg at the time of
             enrollment

          -  Must have adequate oral intake of > 1500 calories/day and be able to maintain
             hydration OR have access for supplemental enteral feeding (nasoenteral tube, feeding
             jejunostomy, or percutaneous endoscopic gastrostomy tube)

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for pancreatic cancer

          -  More than 28 days since prior and no anticipated need for concurrent major surgical
             procedures

          -  More than 7 days since prior minor surgical procedures such as laparoscopy, fine
             needle aspirations, or core biopsies

          -  No treatment plan requiring treatment of > 50% of the liver at a dose > 30 Gy or > 50%
             of the total kidney volume at a dose > 18 Gy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No oral or parenteral anticoagulation unless patients is receiving a stable dose of
             anticoagulant
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Peter O'Dwyer, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00602602

Organization ID

CDR0000580812

Secondary IDs

UPCC-04206

Responsible Party

Sponsor

Study Sponsor

Abramson Cancer Center of the University of Pennsylvania

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Peter O'Dwyer, MD, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania


Verification Date

August 2018