EXTENDED SCHEDULE OF GROWING DOSES OF TEMOZOLOMIDE COMPARED TO DACARBAZINE FOR METASTASIC MELANOMA TREATMENT STAGE IV: RANDOMIZED STUDY OF PHASE III OF THE MELANOMA GROUP OF THE EORTC

Not Applicable

Completed

• Conditions: -C439 Malignant melanoma of skin, unspecified; Malignant melanoma of skin, unspecified; C439

• Registration Number: PER-083-04
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-03
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified