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Status:

COMPLETED

Capecitabine, Bevacizumab, and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

NRG Oncology

Conditions:

Adenocarcinoma of the Pancreas

Stage II Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 an...

Detailed Description

PRIMARY OBJECTIVES: I. Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine, bevacizumab, and radiotherapy followed by maintenanc...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • Clinically significant peripheral artery disease
  • No unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia \[i.e., atrial fibrillation or paroxysmal supraventricular tachycardia\])
  • Patients with an atrial arrhythmia are eligible provided the condition is well controlled on stable medication
  • No New York Heart Association class II-IV congestive heart failure
  • No history of arteriovenous malformation
  • No history of aneurysm
  • No uncontrolled hypertension (i.e., blood pressure \> 160/90 mm Hg with medication)
  • No other clinically significant cardiac disease
  • No AIDS
  • No significant infection
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Not pregnant
  • No nursing during and for ≥ 3-4 months after completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3-4 months after completion of study treatment
  • No history of gastrointestinal fistula or perforation
  • No other malignancy within the past two years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
  • No significant traumatic injury within the past 4 weeks
  • No serious nonhealing wound or ulcer
  • No current healing fracture
  • No known or suspected dihydropyrimidine dehydrogenase deficiency
  • No other medical condition that would preclude study participation
  • No concurrent interleukin-11
  • No prior chemotherapy for pancreatic cancer
  • More than 2 years since prior chemotherapy for another malignancy
  • No prior radiotherapy to the planned irradiation field
  • No concurrent intensity modulated radiotherapy
  • No other concurrent radiotherapy
  • See Disease Characteristics
  • More than 4 weeks since prior major surgical procedure or open biopsy
  • More than 1 week since prior fine needle aspiration or core biopsy
  • No prior organ transplantation
  • No concurrent major surgical procedure
  • More than 30 days since prior and no concurrent cimetidine
  • Concurrent ranitidine or a drug from another anti-ulcer class allowed
  • More than 4 weeks since prior and no concurrent sorivudine or brivudine
  • No concurrent warfarin during chemoradiotherapy
  • Concurrent warfarin allowed beginning 2 weeks after completion of chemoradiotherapy
  • Concurrent low molecular weight heparin allowed (at any time during study participation)
  • No other concurrent investigational agents
  • No other concurrent cytotoxic agents

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2007

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT00114179

    Start Date

    January 1 2005

    End Date

    May 1 2007

    Last Update

    October 30 2020

    Active Locations (1)

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    Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, United States, 19103