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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Fotemustine

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