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Intraocular MelanomaPhase 3NCT00110123

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

A Phase 3 study testing fotemustine and isolated perfusion in people with Intraocular Melanoma and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraocular Melanoma, Metastatic Cancer
What is being tested?
fotemustine and isolated perfusion
How many people
171 participants
Where
8 sitesin 4 countries
Study dates
Jan 2005to Jun 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Italy4 sites

  • European Institute of Oncology

    Milan, 20141

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Universita di Siena

    Siena, 53100

Other trials in Italy

United Kingdom2 sites

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

Other trials in United Kingdom

Poland1 site

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

    Warsaw, 02-781

Other trials in Poland

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
fotemustine, isolated perfusion
Keywords
liver metastases, ciliary body and choroid melanoma, medium/large size, iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma
Medical subject headings
Uveal Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fotemustineDrug

  • isolated perfusionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of survival

Secondary outcomes (4)

  1. Progression-free survival

  2. Best response as assessed by RECIST criteria

  3. Duration of response

  4. Toxicity as assessed by CTCAE v3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionJun 2011

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110123
Sponsor's protocol ID
EORTC-18021
Other IDs
EORTC-18021, 2004-002245-12, 2004
Status last verified
Sep 2012
First submitted
3 May 2005
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 24510314

  • 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.

    PubMed 22027909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fotemustine and isolated perfusion in people with Intraocular Melanoma and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy, United Kingdom, Poland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00110123, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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