Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

Phase 3 Completed 269 enrolled National Cancer Institute, Naples

RandomizedFactorialOpen-labelTreatment

Summary

This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.

Timeline

Start: 2002-04
Primary completion: 2011-02
Completion: 2011-02

Outcome

Missed primary endpoint

paper Addition of fotemustine did not significantly improve overall survival (OS) (p=0.28) or progression-free survival (PFS) (p=0.55); PMID 23402397 ↗

Publications

Results Daponte A, Signoriello S, Maiorino L, Massidda B, Simeone E, Grimaldi AM, Caraco C, Palmieri G, Cossu A, Botti G, Petrillo A, Lastoria S, Cavalcanti E, Aprea P, Mozzillo N, Gallo C, Comella G, Ascierto PA; Southern Italy Cooperative Oncology Group (SICOG). Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fotemustine	Small molecule	100 mg/m2	—
Subject	interferon alfa-2b	Protein / enzyme biologic	5e+06 iu	—
Background	Dacarbazine	Small molecule	900 mg/m2	—