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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
859
oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
Overall Survival
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Time frame: The final analysis was to be performed when at least 616 deaths had occurred.
Progression Free Survival
Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
Time frame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
Objective Response Rate in Subjects With Measurable Lesions
Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
Time frame: Treatment continued until disease progression or unacceptable toxicity.
Duration of Objective Response
Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
Time frame: Treatment continued until disease progression or unacceptable toxicity.
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