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

May 3, 2005
September 20, 2012
January 2005
June 2011   (final data collection date for primary outcome measure)
Duration of survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00110123 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Intraocular Melanoma
  • Metastatic Cancer
  • Drug: fotemustine
  • Drug: isolated perfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
171
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Poland,   Switzerland,   United Kingdom
 
NCT00110123
EORTC-18021, EORTC-18021, 2004-002245-12
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Serge Leyvraz, MD Centre Hospitalier Universitaire Vaudois
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP