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Status:

COMPLETED

Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is st...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of sorafenib and erlotinib in patients with metastatic or unresectable solid tumors. Secondary * Determine ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed solid tumor
  • Metastatic or unresectable disease
  • Standard curative or palliative measures do not exist OR are no longer effective
  • Measurable disease by radiography (for patients treated at the maximum tolerated dose \[MTD\] only)
  • Tumor accessible for serial biopsies (for patients treated at the MTD only)
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No bleeding diathesis or coagulopathy
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times ULN
  • PT INR ≤ 1.5 unless on full-dose warfarin
  • Renal
  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 140 mm Hg or diastolic BP \> 90 mm Hg despite medication)
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Ophthalmic
  • No abnormalities of the cornea, including any of the following:
  • Dry eye syndrome
  • Sjögren's syndrome
  • Congenital abnormalities (e.g., Fuch's dystrophy)
  • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
  • Gastrointestinal
  • No active peptic ulcer disease that would impair the ability to swallow pills
  • No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to undergo serial biopsies, positron emission tomography, and CT scanning (for patients treated at the MTD only)
  • No ongoing or active infection
  • No significant traumatic injury within the past 3 weeks
  • No history of allergic reaction to drugs of similar chemical or biological composition to study drugs
  • No psychiatric illness or social situation that would preclude study compliance
  • No other condition that would impair the ability to swallow pills
  • No other uncontrolled illness
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • Chemotherapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy (except for low dose, non-myelosuppressive radiotherapy) and recovered
  • Surgery
  • More than 3 weeks since prior major surgery
  • No prior surgical procedure affecting absorption
  • Other
  • No prior sorafenib or erlotinib
  • No other prior agents targeting Raf, vascular endothelial growth factor (VEGF), VEGF receptor, or epidermal growth factor receptor
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent CYP3A4 inducers (e.g., rifampin or Hypericum perforatum \[St. John's wort\])
  • No other concurrent anticancer therapy
  • Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided PT INR \< 1.1 times upper limit of normal (ULN)
  • Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided both of the following criteria are met:
  • Patient has an in range INR (between 2-3) while on a stable-dose of oral anti-coagulant OR a stable-dose of low molecular weight heparin
  • No active bleeding OR pathological condition that would confer a high risk of bleeding (e.g., tumor involving a major vessel or known varices)

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT00126620

    Start Date

    September 1 2005

    Last Update

    July 23 2015

    Active Locations (2)

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

    Page 1 of 1 (2 locations)

    1

    Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, Canada, L8V 5C2

    2

    Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9