Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
Trial Information
Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Inclusion Criteria:
- 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
Exclusion Criteria:
- Ocular melanomas
- Brain Metastases
- Prior cytokine or chemotherapy for stage IV disease
- Pregnant or nursing women
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
The final analysis was to be performed when at least 616 deaths had occurred.
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
P03267
NCT ID:
NCT00091572
Start Date:
October 2004
Completion Date:
December 2007
Related Keywords:
- Melanoma
- Metastatic Melanoma
- Melanoma
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