|Phase III||Treatment||Completed||18 and over||Pharmaceutical / Industry||P03267|
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
- Histologically confirmed, stage IV, surgically incurable melanoma
- Age 18 years or older
- World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Meets protocol requirements for specified laboratory values
- Must be able to take oral medication
- Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).
- Women of childbearing potential and men must be practicing a medically approved contraception.
- Must provide written informed-consent to participate in the study.
- Must have full recovery from major surgery or adjuvant treatment
- No clinically uncontrolled infectious disease including HIV or AIDS-related illness
- Ocular melanomas
- Brain Metastases
- Prior cytokine or chemotherapy for stage IV disease
- Pregnant or nursing women
Trial Lead Organizations/Sponsors
Schering-Plough Research InstituteEuropean Organization for Research and Treatment of Cancer
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00091572
ClinicalTrials.gov processed this data on October 17, 2013
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