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Status:

TERMINATED

Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Intraocular Melanoma

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in...

Detailed Description

OBJECTIVES: Primary * Compare overall survival of patients with surgically incurable or unresectable liver metastases secondary to uveal melanoma treated with fotemustine administered as an intraven...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed liver metastases secondary to uveal melanoma
  • Surgically incurable or unresectable disease
  • No detectable extrahepatic metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Hepatic
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • ALT and AST \< 5 times ULN
  • Alkaline phosphatase \< 5 times ULN
  • Gamma-glutamyltransferase \< 5 times ULN
  • Lactic dehydrogenase \< 5 times ULN
  • Renal
  • BUN \< 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No uncontrolled angina pectoris
  • No myocardial infarction within the past 6 months
  • No uncontrolled high blood pressure
  • No evolutive intracranial hypertension
  • No other severe cardiac disease
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active gastroduodenal ulcer
  • No diabetes
  • No active or uncontrolled infection
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • No other uncontrolled severe medical condition
  • No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunologic or biologic therapy
  • Chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy for metastatic disease
  • No concurrent radiotherapy
  • Surgery
  • Recovered from prior major surgery
  • Other
  • No prior antineoplastic drugs for metastatic disease
  • More than 4 weeks since prior investigational drugs
  • No other concurrent anticancer agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    171 Patients enrolled

    Trial Details

    Trial ID

    NCT00110123

    Start Date

    January 1 2005

    Last Update

    September 24 2012

    Active Locations (8)

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

    Page 1 of 2 (8 locations)

    1

    European Institute of Oncology

    Milan, Italy, 20141

    2

    Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, Italy, 80131

    3

    Azienda Ospedaliera di Padova

    Padua, Italy, 35128

    4

    Universita di Siena

    Siena, Italy, 53100