Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

PHASE3CompletedINTERVENTIONAL
Enrollment

859

Participants

Timeline

Start Date

October 20, 2004

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Melanoma
Interventions
DRUG

Temozolomide

"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."

DRUG

Dacarbazine

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.

All Listed Sponsors
collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00091572 - Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267) | Biotech Hunter | Biotech Hunter