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Status:

COMPLETED

Sorafenib in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Kidney Cancer

Lead Sponsor:

UNC Lineberger Comprehensive Cancer Center

Collaborating Sponsors:

Doris Duke Charitable Foundation

Bayer

Conditions:

Kidney Cancer

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before surgery may make the tum...

Detailed Description

OBJECTIVES: Primary * Determine the safety and feasibility of systemic sorafenib tosylate therapy when given prior to definitive nephrectomy in patients with stage II-IV renal cell carcinoma (RCC). ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of renal cell carcinoma (RCC) as confirmed by either of the following:
  • Radiographic documentation by MRI or CT scan
  • Histological evidence of primary RCC
  • Stage II-IV disease, as defined by any of the following:
  • T \> 7 cm
  • Renal vein involvement
  • Local invasion
  • Evidence of lymph node involvement
  • Distant metastatic disease
  • Deemed suitable for nephrectomy by a urologist
  • No requirement for surgery earlier than 4 weeks from study entry
  • No known brain metastasis
  • Patients with neurological symptoms must undergo a CT scan or brain MRI to exclude brain metastasis
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • 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 ≤ 2.5 times ULN or glomerular filtration rate ≥ 50 mL/min
  • INR ≤ 1.5 AND PTT normal
  • Stable INR required at baseline for patients on warfarin
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile women must use effective contraception
  • Fertile men must use effective contraception during and for ≥ 2 months after the last dose of sorafenib tosylate
  • No other active primary malignancy except skin cancer
  • No active coronary artery disease
  • No active bleeding diathesis
  • Closely monitored therapeutic anticoagulation allowed
  • No cardiac disease, including any of the following:
  • New York Heart Association class III-IV congestive heart failure
  • Unstable angina (i.e., anginal symptoms at rest) or new onset angina (i.e., beginning within the past 3 months)
  • Myocardial infarction within the past 6 months
  • No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
  • No known HIV infection or chronic hepatitis B or C
  • No active, clinically serious infection \> grade 2
  • No thrombolic or embolic events, such as a cerebrovascular accident or transient ischemic attacks, within the past 6 months
  • No pulmonary hemorrhage or bleeding event ≥ grade 2 within the past 4 weeks (≥ grade 3 for any nonpulmonary hemorrhage or bleeding event)
  • No serious nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 4 weeks
  • No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
  • No condition that impairs the patient's ability to swallow whole pills
  • No malabsorption problem
  • PRIOR CONCURRENT THERAPY:
  • No major surgery or open biopsy within the past 4 weeks
  • Concurrent anticoagulation therapy (e.g., warfarin or heparin) allowed
  • No other concurrent investigational or commercial agents or therapies for RCC
  • No concurrent Hypericum perforatum (St. John's wort) or rifampin

Exclusion

    Key Trial Info

    Start Date :

    November 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2015

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00405366

    Start Date

    November 1 2006

    End Date

    July 1 2015

    Last Update

    April 18 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States, 27599-7295