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Status:

COMPLETED

Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adenocarcinoma of the Pancreas

Recurrent Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced panc...

Detailed Description

OBJECTIVES: I. Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib. II. Compare the toxi...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Advanced disease
  • Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
  • Not amenable to curative surgery or radiotherapy
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Pleural effusions and ascites are not considered measurable lesions
  • No CNS disease, including primary brain tumors or brain metastasis
  • No tumor invasion into the duodenum
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • No history of bleeding diatheses
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • INR ≤ 1.5 (≤ 3 for patients on warfarin)
  • No esophageal varices
  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • Urine protein \< 1+
  • 24-hour urine protein \< 500 mg
  • No history of a recent cerebrovascular accident
  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No peripheral vascular disease ≥ grade II
  • None of the following arterial thromboembolic events within the past 6 months:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • HIV negative
  • No significant traumatic injury within the past 28 days
  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No allergic reactions to compounds similar to bevacizumab, cetuximab, or erlotinib (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
  • No serious or non-healing wound, ulcer, or bone fracture
  • No active infection requiring antibiotics
  • No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No prior bevacizumab or cetuximab
  • No other prior vascular endothelial growth factor inhibitors
  • No prior gemcitabine
  • No prior cytotoxic chemotherapy for metastatic disease
  • At least 4 weeks since prior adjuvant chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • At least 4 weeks since prior radiotherapy
  • Must have a site of measurable disease outside the radiation port
  • No prior surgical procedure affecting absorption
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy
  • No concurrent major surgical procedures
  • No prior erlotinib
  • No other prior epidermal growth factor receptor inhibitors
  • At least 30 days since prior investigational drugs
  • More than 1 month since prior thrombolytic agents
  • Concurrent warfarin or low molecular weight heparin allowed provided the following criteria are met:
  • Currently therapeutic on a stable dose
  • INR target range ≤ 3
  • Patients undergo weekly INR testing
  • No evidence of active bleeding or pathological condition that carries high risk of bleeding (e.g., tumor invading adjacent organs or esophageal varices)
  • No concurrent chronic daily therapy with aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
  • No other concurrent antiplatelet medications
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapies or agents
  • No other concurrent investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2011

    Estimated Enrollment :

    143 Patients enrolled

    Trial Details

    Trial ID

    NCT00091026

    Start Date

    July 1 2004

    End Date

    January 1 2011

    Last Update

    May 15 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    University of Chicago

    Chicago, Illinois, United States, 60637