EUCTR2004-002245-12-GBActive, not recruitingNot Applicable
/A
European Organisation for the Research and Treatment of Cancer0 sites262 target enrollmentStarted: February 17, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 262
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 < 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
Exclusion Criteria
- Not provided
Investigators
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/AMedDRA version: 13.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002034-38-DKRgshospitalet120