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Status:

COMPLETED

Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow t...

Detailed Description

OBJECTIVES: Primary * To determine the efficacy of sorafenib tosylate in combination with erlotinib hydrochloride in patients with unresectable pancreatic cancer. Secondary * To determine the resp...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Microscopically confirmed diagnosis of pancreatic adenocarcinoma
  • Unresectable disease
  • No neuroendocrine tumors or cystadenocarcinoma
  • Measurable or evaluable disease by RECIST criteria
  • No known brain metastases
  • Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
  • Creatinine ≤ 1.5 times ULN
  • INR \< 1.5 or PT/PTT normal unless patients are receiving anticoagulation treatments
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception before, during, and for at least 6 months after completion of study treatment
  • Able to swallow whole pills
  • No patients who currently smoke
  • No cardiac disease, including any of the following:
  • NYHA class III-IV congestive heart failure
  • Unstable angina (anginal symptoms at rest)
  • New-onset angina (began within the past 3 months)
  • Myocardial infarction within the past 6 months
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management
  • No arterial thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 in the past 4 weeks
  • No other hemorrhage/bleeding event ≥ CTCAE grade 3 in the past 4 weeks
  • No significant traumatic injury in the past 4 weeks
  • No known untreated malabsorption problem (e.g., ulcerative colitis, Crohn's disease)
  • No known HIV positivity or chronic hepatitis B or C
  • No known or suspected allergy to sorafenib tosylate or erlotinib hydrochloride
  • No active clinically serious infection \> CTCAE grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No evidence or history of bleeding diathesis or coagulopathy (except for cancer-related blood clots)
  • No dermatitis ≥ CTCAE grade 2 at baseline
  • No patients who currently smoke
  • PRIOR CONCURRENT THERAPY:
  • No prior treatment with antiangiogenics (e.g., bevacizumab, thalidomide, marimastat, interferon alfa, vatalanib, vandetanib, ZD6126, sorafenib, semaxanib, sunitinib, axitinib)
  • No more than one line of prior therapy for metastatic disease
  • More than 4 weeks since prior major surgery or open biopsy
  • No concurrent strong CYP34A inhibitors or inducers
  • Concurrent warfarin or heparin allowed with the approval of the principal investigator

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2012

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00837876

    Start Date

    October 1 2008

    End Date

    November 1 2012

    Last Update

    June 25 2014

    Active Locations (6)

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

    Page 1 of 2 (6 locations)

    1

    Purchase Cancer Group - Paducah

    Paducah, Kentucky, United States, 42002

    2

    Erlanger Cancer Center at Erlanger Hospital - Baroness

    Chattanooga, Tennessee, United States, 37403

    3

    Baptist Regional Cancer Center at Baptist Riverside

    Knoxville, Tennessee, United States, 37901

    4

    Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee, United States, 37064