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

Phase 3 Completed 859 enrolled Merck Sharp & Dohme LLC European Organisation for Research and Treatment of Cancer - EORTC · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2004-10-20
Primary completion: 2007-12-31
Completion: 2007-12-31

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Temozolomide vs Dacarbazine; p = 0.9999; Hazard Ratio (HR) 1.00 (95% CI 0.86 to 1.17); Log Rank NCT00091572 ↗

paper does not improve OS and PFS in metastatic melanoma when compared to standard dose dacarbazine. PMID 21600759 ↗

Publications

Results Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dacarbazine	Small molecule	1000 mg/m2	Intravenous
Subject	Temozolomide	Small molecule	150 mg/m2	Oral