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

NCT00110123 | Terminated Phase 3

• 2 other identifiers: EORTC-180212004-002245-12
• Study Type: interventional
• Target: 171
• Locations: 4 countries
• Sites: 8

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.

Conditions

Intraocular Melanoma; Metastatic Cancer

Keywords

liver metastases; ciliary body and choroid melanoma, medium/large size; iris melanoma; extraocular extension melanoma; recurrent intraocular melanoma; metastatic intraocular melanoma

Outcome Measures

Primary Outcomes (1)

• Duration of survival

Secondary Outcomes (4)

• Progression-free survival

• Best response as assessed by RECIST criteria

• Duration of response

• Toxicity as assessed by CTCAE v3

Interventions

fotemustine DRUG

isolated perfusion DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (8)

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Universita di Siena

Siena, 53100, Italy

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, 02-781, Poland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (2)

• Leyvraz S, Piperno-Neumann S, Suciu S, Baurain JF, Zdzienicki M, Testori A, Marshall E, Scheulen M, Jouary T, Negrier S, Vermorken JB, Kaempgen E, Durando X, Schadendorf D, Gurunath RK, Keilholz U. Hepatic intra-arterial versus intravenous fotemustine in patients with liver metastases from uveal melanoma (EORTC 18021): a multicentric randomized trial. Ann Oncol. 2014 Mar;25(3):742-746. doi: 10.1093/annonc/mdt585. Epub 2014 Feb 7.

  PMID: 24510314 DERIVED

• Orcurto V, Denys A, Voelter V, Schalenbourg A, Schnyder P, Zografos L, Leyvraz S, Delaloye AB, Prior JO. (18)F-fluorodeoxyglucose positron emission tomography/computed tomography and magnetic resonance imaging in patients with liver metastases from uveal melanoma: results from a pilot study. Melanoma Res. 2012 Feb;22(1):63-9. doi: 10.1097/CMR.0b013e32834d3dcb.

  PMID: 22027909 DERIVED

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis

Interventions

fotemustine

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge Leyvraz, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2011
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

PL (1); CH (1); IT (4); GB (2)