Conditions: Melanoma
Keywords: Metastatic Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 859
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) arm 2: dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

Interventions: intervention 1: Temozolomide intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: