None listed
Conditions
Interventions
Group A Type of group
TMZ: 150 mg / m2 / day p.o.r. 7 days with treatment - 7 days without treatment, continuously until the progression of the disease is detected.
Group name:Group B Type of group
Dacarbazine: 1000 mg / m2 / day iv day 1 every 3 weeks until the progression of the disease is detected.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with histologically confirmed stage IV malignant metastatic melanoma (surgically incurable or inerachable), including unknown primary mucosal melanoma. Patients with disease in 2 regional lymphatic stations (even if they are contiguous) are considered stage IV. Ocular melanomas are excluded. Patients must present at least evaluable disease to meet the eligibility criteria for the study (the participation of patients with metastatic disease detectable only by PET) is not allowed [abbreviations in English of Tomography by Emission of Positrons] • Patients should not present clinical evidence of brain metastasis • Patients must not have received prior chemotherapy or any cytokine for stage IV disease. The following therapies are allowed: Coadjuvant therapy with cytokines or vaccines for stage I tumors, or not excised, Previous therapy with vaccines (other than cytokines) for stage IV disease, Non-radical surgery for stage IV disease, Chemotherapy or prior cytokine for local regional disease by perfusion therapy of the isolated limb • WHO performance status (ECOG) of 0-1 • Age 18 years and older • The patients must present adequate hematological, renal and hematological functions according to the laboratory values ​​that appear next in a period of 14 days, inclusive, before the randomization • Patients must have recovered from any effect produced by the practice of major surgery • Patients should not have frequent vomiting or medical conditions that could interfere with the oral intake of the medication, (eg, partial bowel obstruction) • Informed consent
Exclusion criteria
Exclusion criteria: • Clinical evidence of brain metastasis • Have previously received chemotherapy or any cytokine for stage IV disease. The following therapies are allowed: Coadjuvant therapy with cytokines or vaccines for stage I tumors, or not excised, Previous therapy with vaccines (other than cytokines) for stage IV disease, Non-radical surgery for stage IV disease, Chemotherapy or prior cytokine for local regional disease by perfusion therapy of the isolated limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the time elapsed from the date of randomization until the date of death for any reason (everything possible should be done to document the cause of death). Patients who are still alive at the last follow-up will be considered as an observational record. Measure:General survival Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be measured from the date of randomization to the date of progression or death, whatever the cause. Patients who do not present progression and who are still alive at the last follow-up will be considered as an observational record. Measure:Progression free survival Timepoints:to the date of progression or death ; Outcome name:The objective response of the tumor will be measured, as a secondary endpoint of this study, according to the RECIST criteria. The response criteria are essentially based on a set of measurable lesions identified at the beginning as fixed lesions, and will be followed until the progression of the disease. Measure:The objective response rate (RR) in patients with measurable lesions Timepoints:until the progression of the disease. ; Outcome name:The response criteria are essentially based on a set of measurable lesions identified at the beginning as fixed lesions, and will be followed until the progression of the disease. Measure:La duracion de la respuesta objetiva en pacientes con lesiones medibles Timepoints:until the progression of the disease. ; Outcome name:Emergence of adverse events Measure:Safety and tolerance of the frequent dose schedule of temozolomide Timepoints:During treatment | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed