Intravenous versus intra-arterial fotemustine chemotherapy in patients with liver metastases from uveal melanoma: a randomized phase III study of the EORTC Melanoma Group.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002245-12-DE

Enrollment

262

Registered

2004-09-23

Start date

2005-01-27

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal melanomas with specific hepatic tropism MedDRA version: 13.1 Level: HLT Classification code 10030052 Term: Ocular melanomas System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Muphoran Product Code: S 10036 Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Fotemustine CAS Number: 92118-27-9 Current Sponsor code: S 10036 Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients with histologically or cytologically confirmed, surgically incurable or unresectable liver metastases from uveal melanoma. Unresectable defined as no possibility to resect completely all tumour lesions. ? No detectable extra-hepatic diseases are allowed. ? Patients must not have received any prior systemic chemotherapy or radiotherapy for metastatic disease. ? Age greater than or equal to 18 years. ? Patients must have WHO (ECOG) performance status of 0, 1 or 2. ? Patients must have adequate hematologic, renal and liver function as defined by laboratory values below performed within 14 days, inclusive, prior to study randomization: 1. Absolute neutrophil count (ANC) = 2.0 x 109/l. 2. Platelet count = 100 x 109/l. 3. Hemoglobin = 10 g/dl (> 6.2 mmol/l). 4. Urea and serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): The secondary end-points of this phase III trial are: ? Progression free survival (PFS). ? Response rate (RR). ? Duration of objective response. ? Pattern of progression. ? Treatment related toxicities and catheter-related complications.;Timepoint(s) of evaluation of this end point: 04/2015	—

Primary

Measure	Time frame
Main Objective: To determine whether the intra-arterial administration of fotemustine, compared to its intravenous administration, is improving the Overall Survival in patients suffering form uveal melanoma metastetized to the liver.;Secondary Objective: ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: 04/2015	—

Countries

Germany, Italy, Switzerland, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026