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Status:

COMPLETED

Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Detailed Description

OBJECTIVES: Primary * Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab, gemcitabine, and oxaliplatin. Secondary * Determine the ob...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed ductal cell or undifferentiated adenocarcinoma of the pancreas
  • Previously untreated metastatic disease
  • No islet cell or acinar cell carcinoma or cystadenocarcinoma
  • No invasion of adjacent organs (i.e., duodenum or stomach) or major blood vessels ( i.e., superior mesenteric artery or celiac artery)
  • No CNS metastasis
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 6 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10.0 g/dL
  • No bleeding diathesis or uncontrolled coagulopathy
  • No bleeding events within the past 6 months
  • Hepatic
  • Bilirubin ≤ 2 times upper limit of normal (ULN) (stenting allowed)
  • AST ≤ 5 times ULN
  • No esophageal varices
  • Renal
  • Creatinine ≤ 2 times ULN
  • Proteinuria \< 1+ by dipstick or urinalysis OR
  • Protein \< 1 g/24-hr urine collection
  • No nephrotic syndrome
  • Cardiovascular
  • No New York Heart Association class II-IV congestive heart failure
  • No symptomatic, unstable angina, or coronary artery disease
  • No uncontrolled cardiac arrhythmias
  • No myocardial infarction within the past 6 months
  • No uncontrolled hypertension
  • No history of cerebrovascular events
  • No clinically significant peripheral arterial disease
  • No other clinically significant cardiac disease
  • Pulmonary
  • No hemoptysis within the past 6 months
  • Immunologic
  • No history of allergy or hypersensitivity to bevacizumab, oxaliplatin, or gemcitabine
  • No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known allergy to other platinum compounds
  • No ongoing or active infection
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No serious, non-healing wound, ulcer, or bone fracture
  • No pre-existing peripheral neuropathy \> grade 1
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or prostate cancer with a Gleason score \< 7
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No gastrointestinal bleeding within the past 6 months
  • No unresolved physical trauma within the past 4 weeks
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 months since prior immunotherapy or biologic therapy
  • No prior adjuvant bevacizumab
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during the first course of study therapy
  • Chemotherapy
  • Recovered from prior chemotherapy
  • More than 4 months since prior adjuvant chemotherapy for completely resected disease
  • At least 4 months since prior chemoradiotherapy for locally advanced disease
  • More than 4 months since prior gemcitabine as a radiosensitizer or as maintenance therapy
  • No prior cytotoxic chemotherapy for metastatic disease
  • No prior adjuvant oxaliplatin
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Chemotherapy
  • More than 4 months since prior radiotherapy
  • No prior radiotherapy to \> 25% of bone marrow
  • No prior radiotherapy to sole site of measurable disease unless there is radiologically confirmed progression of the irradiated tumor
  • No concurrent radiotherapy
  • Surgery
  • More than 4 weeks since prior major surgery or trauma and recovered
  • No concurrent surgery
  • Other
  • More than 2 weeks since prior and no concurrent thrombolytic agents
  • Anticoagulation therapy with warfarin or low molecular weight heparin is allowed provided the following criteria are met:
  • At least 2 weeks at a stable dose
  • INR 2-3
  • No active bleeding or pathologic condition that confers a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No recent or concurrent participation in another study of experimental drugs

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2010

    Estimated Enrollment :

    53 Patients enrolled

    Trial Details

    Trial ID

    NCT00112528

    Start Date

    June 1 2005

    End Date

    November 1 2010

    Last Update

    December 13 2016

    Active Locations (201)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 51 (201 locations)

    1

    Mobile Infirmary Medical Center

    Mobile, Alabama, United States, 36652-2144

    2

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259

    3

    Aurora Presbyterian Hospital

    Aurora, Colorado, United States, 80012

    4

    Boulder Community Hospital

    Boulder, Colorado, United States, 80301-9019