Temozolomide and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery.

Timeline

Start

2007-12

Primary completion

2010-12

Completion

2011-10

Outcome

Met primary endpoint

paper CONCLUSIONS: The primary end point was surpassed showing promising activity of this bevacizumab/temozolomide combination with a favourable toxicity profile. PMID 21527587 ↗

Publications

• Results von Moos R, Seifert B, Simcock M, Goldinger SM, Gillessen S, Ochsenbein A, Michielin O, Cathomas R, Schlappi M, Moch H, Schraml PH, Mjhic-Probst D, Mamot C, Schonewolf N, Dummer R; Swiss Group for Clinical Cancer Research (SAKK). First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07). Ann Oncol. 2012 Feb;23(2):531-6. doi: 10.1093/annonc/mdr126. Epub 2011 Apr 28.
• Results Dummer R, Michielin O, Seifert B, et al.: First-line temozolomide (TEM) combined with bevacizumab (BEV) in metastatic melanoma (MM): A multicenter phase II trial (SAKK 50/07). [Abstract] J Clin Oncol 28 (Suppl 15): A-8521, 2010.
• Results Fuerstenberger G, Boneberg E, Simcock M, et al.: Predictive and prognostic potential of angiogenic serum factors and circulating endothelial cells in metastatic melanoma patients receiving temozolamide plus bevacizumab (SAKK 50/07). [Abstract] J Clin Oncol 28 (Suppl 15): A-8585, 2010.
• Results Schraml P, von Teichman A, Mihic-Probst D, Simcock M, Ochsenbein A, Dummer R, Michielin O, Seifert B, Schlappi M, Moch H, von Moos R. Predictive value of the MGMT promoter methylation status in metastatic melanoma patients receiving first-line temozolomide plus bevacizumab in the trial SAKK 50/07. Oncol Rep. 2012 Aug;28(2):654-8. doi: 10.3892/or.2012.1826. Epub 2012 May 18.

Drugs

Indications