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Status:

COMPLETED

Bevacizumab, Everolimus, and Erlotinib in Treating Patients With Advanced Solid Tumors

Lead Sponsor:

Herbert Hurwitz, MD

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 * Estimate the maximum tolerated dose (MTD)/recommended phase II regimen of everolimus and erlotinib hydrochloride when given with bevacizumab in patients with advanced solid tum...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed malignancy
  • Metastatic or unresectable disease
  • Standard curative or palliative measures do not exist OR are no longer effective
  • No CNS metastases
  • No centrally-located non-small cell lung cancer
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Leukocytes ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN (5 times ULN if known hepatic metastases)
  • Urine protein to creatinine ratio ≤ 1.0 OR urine protein \< 1 g by 24 hour urine collection
  • Creatinine clearance ≥ 50 mL/min OR creatinine normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for up to 4 months after study treatment has stopped
  • No uncontrolled hypertriglyceridemia (i.e., fasting serum triglyceride \> 350 mg/dL)
  • No uncontrolled hypercholesterolemia (i.e., fasting serum cholesterol \> 300 mg/dL)
  • No poorly controlled hypertension (i.e., blood pressure \> 160/100 mm Hg)
  • No poorly controlled or clinically significant atherosclerotic vascular disease
  • No thrombosis within 6 months
  • No venous thromboembolic event within 6 months
  • No arterial thromboembolic events within 12 months
  • No cerebrovascular accident or transient ischemic attack in past 12 months
  • No myocardial infarction or unstable angina in past 12 months
  • No clinically significant peripheral vascular disease in past 12 months
  • No New York Heart Association class II-IV congestive heart failure
  • Atrial or supraventricular tachycardias well controlled with beta blocker or calcium channel blocker allowed
  • Chronic pacemaker use allowed
  • No serious cardiac arrhythmia requiring medication
  • No other clinically significant cardiovascular disease
  • No hemoptysis \> 1 tablespoon within 6 months
  • No presence of bleeding diathesis
  • No coagulopathy
  • No presence of significant gastrointestinal (GI) disorders that would affect drug absorption
  • No hemodynamically significant GI bleeding
  • No history of intolerance to bevacizumab, everolimus, or erlotinib
  • No other major bleeding event
  • No ongoing or active infection
  • No psychiatric illness or social situations that would limit safety or compliance with study requirements
  • No other uncontrolled intercurrent illness
  • PRIOR CONCURRENT THERAPY:
  • No angioplasty or cardiac or vascular stenting within the past 12 months
  • No major surgery within past 28 days
  • No other investigational agents within past 28 days
  • No chemotherapy for cancer within past 21 days
  • No biologic therapy for cancer within past 21 days
  • No radiation therapy for cancer within past 21 days
  • No hormonal therapy for cancer within past 21 days
  • No minor surgical procedures within past 14 days
  • No concurrent antiplatelet agents other than aspirin \< 325 mg/day
  • No use of statin drugs other than pravastatin or atorvastatin
  • Initiation of blood pressure (BP) medication is permitted prior to study entry provided that BP \< 150/90 mm Hg on 3 measurements over one week (study day -7 to 1) before starting treatment
  • No concurrent grapefruit juice
  • No concurrent therapeutic anticoagulation
  • Prophylactic low-dose anticoagulation for indwelling catheters is permitted
  • No concurrent administration of any of the following drugs:
  • Nicardipine
  • Verapamil
  • Clotrimazole
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Cisapride
  • Metoclopramide
  • Bromocriptine
  • Cimetidine
  • Danazol
  • HIV-protease inhibitors (e.g., ritonavir, indinavir)
  • Hypericum perforatum (St. John's wort)
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Diltiazem
  • Rifabutin
  • Rifapentine
  • Rifampin

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2014

    Estimated Enrollment :

    65 Patients enrolled

    Trial Details

    Trial ID

    NCT00276575

    Start Date

    March 1 2005

    End Date

    September 1 2014

    Last Update

    November 19 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710