/A
- Conditions
- veal melanomas with specific hepatic tropismMedDRA version: 7.0Level: HLTClassification code 10030052
- Registration Number
- EUCTR2004-002245-12-GB
- Lead Sponsor
- European Organisation for the Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 262
? 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 < 1.5 times upper limit of laboratory normal (ULN).
5. Total serum bilirubin < 1.5 times ULN.
6. ALAT or ASAT < 5 times ULN.
7. Alkaline phosphatase < 5 times ULN.
8. Gammaglutamyltransferase (GGT) < 5 times ULN.
9. LDH < 5 times ULN.
? Patients must have recovered from any effects of major surgery.
? Patients should not have suffered from previous (unless a DFS interval of at least 5 years) or suffer from concurrent malignancies at other sites with the exception of surgically cured carcinoma insitu of the cervix and basal or squamous cell carcinoma of the skin.
? No severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within 6 months, uncontrolled high blood pressure.
? No investigational drugs within 4 weeks before randomization.
? Absence of any other uncontrolled severe medical condition including active gastro duodenal ulcer, diabetes, active or uncontrolled infection, evolutive intracranial hypertension.
? Patients should not be pregnant or nursing.
? Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to randomization and be practicing medically approved contraceptive precautions.
? Men should use an effective method of contraception.
? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
? Before patient registration/randomization, written informed consent must be given according toICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method