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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00110123
First received: May 3, 2005
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases.

PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma.


Condition Intervention Phase
Intraocular Melanoma
Metastatic Cancer
Drug: fotemustine
Drug: isolated perfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Best response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE v3 [ Designated as safety issue: Yes ]

Enrollment: 171
Study Start Date: January 2005
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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 intravenous infusion vs an intra-arterial hepatic perfusion.

Secondary

  • Compare progression-free survival of patients treated with this drug.
  • Compare the response rate in patients treated with this drug.
  • Compare the duration of objective response in patients treated with this drug.
  • Compare the patterns of progression in patients treated with this drug.
  • Compare treatment-related toxic effects and catheter-related complications in patients treated with this drug.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, lactic dehydrogenase level (normal vs abnormal), and WHO performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fotemustine IV over 1 hour on days 1, 8, and 15 (induction course). Beginning on day 50, patients receive maintenance courses of fotemustine IV over 1 hour every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive fotemustine by a 4-hour intra-arterial (IA) hepatic perfusion on days 1, 8, 15, and 22 (induction course). Beginning on day 57, patients receive maintenance courses of fotemustine by a 4-hour IA hepatic perfusion every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 9 weeks for survival.

PROJECTED ACCRUAL: A total of 262 patients (131 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110123

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Universita di Siena
Siena, Italy, 53100
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Serge Leyvraz, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided by European Organisation for Research and Treatment of Cancer - EORTC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00110123     History of Changes
Other Study ID Numbers: EORTC-18021, EORTC-18021, 2004-002245-12
Study First Received: May 3, 2005
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
liver metastases
ciliary body and choroid melanoma, medium/large size
iris melanoma
extraocular extension melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Uveal Neoplasms
Liver Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Fotemustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014