Clinical trial · Interventional
Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fotemustine | Drug | — | UNRESOLVED |
| isolated perfusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Duration of survival
Secondary outcomes (4)
- measure
- Progression-free survival
- measure
- Best response as assessed by RECIST criteria
- measure
- Duration of response
- measure
- Toxicity as assessed by CTCAE v3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLeyvraz 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
- DERIVEDOrcurto 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