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

Phase 3

Terminated

• Conditions: Intraocular Melanoma; Metastatic Cancer

• Registration Number: NCT00110123
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 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.

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-05-03
• Study First Submitted QC: 2005-05-03
• Study First Posted: 2005-05-04
• Primary Completion: 2011-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Toxicity as assessed by CTCAE v3
Best response as assessed by RECIST criteria
Duration of response

Trial Locations

Locations (8)

European Institute of Oncology; 🇮🇹 Milan, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Naples, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Universita di Siena; 🇮🇹 Siena, Italy

Clatterbridge Centre for Oncology; 🇬🇧 Merseyside, England, United Kingdom

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw; 🇵🇱 Warsaw, Poland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Ninewells Hospital; 🇬🇧 Dundee, Scotland, United Kingdom