Patients with histologically confirmed metastatic melanoma
Conditions
Sponsors
Turku University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of malignant melanoma either locally progressing inoperable or metastatic. Previous adjuvant therapy with interferon is allowed. 2. Age 18 or above 3. Measurable or evaluable disease in accordance with RECIST criteria 4. WHO performance status =2 and normal organ function 5. lab values in protocol 6. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first 7. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures 8. Patient must be able to comply with the protocol 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
Exclusion criteria: 1. Unevaluable disease 2. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery) 3. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed) 4. Clinical or radiological (CT) evidence of CNS metastases 5. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated Basal and squamous cell carcinoma of the skin or In-situ carcinoma of the cervix 6. Serious non-healing wound or ulcer 7. Evidence of bleeding diathesis or coagulopathy 8. Uncontrolled hypertension 9. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 10. Evidence of serious depression or psychosis, which needs continuous medication. 11. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications 12. Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (e.g. chronic use of non-steroidal anti-analgetics) 13. Pregnancy (positive serum pregnancy test) and lactation 14. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 15. Previous chemotherapy for metastatic melanoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate response rate according to RECIST criteria, progression-free survival, time to brain metastases and overall survival ;Secondary Objective: To evaluate safety of this combination (after every 2 cycles) and putative association between serum VEGF levels and response to this therapy;Primary end point(s): To assess the effectiveness of the combination therapy the following variables will be analysed • Response rate according to RECIST criteria • Progression free survival • Time to brain metastases • Duration of overall survival (defined as the time period from the start of therapy to death) • Association between serum VEGF levels and response Safety assessment will consist of evaluating laboratory parameters and adverse events according to NCI CTCAE 3.0 | — |
Countries
Finland
Outcome results
None listed