Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group


Phase 3
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Metastatic Cancer

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Trial Information

Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of survival

Safety Issue:

No

Principal Investigator

Serge Leyvraz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois

Authority:

United States: Federal Government

Study ID:

EORTC-18021

NCT ID:

NCT00110123

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Metastatic Cancer
  • liver metastases
  • ciliary body and choroid melanoma, medium/large size
  • iris melanoma
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • metastatic intraocular melanoma
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Uveal Neoplasms
  • Liver Neoplasms

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