A phase 2 study of temozolomide in patients affected by metastatic colonrectal cancer with hypermethylation of 06-methylguanine-dna-methyltransferase

Primary objectives: - To assess the activity (in terms of response rate according to RECIST 1.1 criteria) of temozolomide (TMZ) in patients with refractory metastatic colorectal cancer with hypermethylation of MGMT
Primary endpoints: - Objective tumor response rate according to RECIST 1.1 criteria
- Duration of response, as the time period from first documentation of response (complete or partial response) to the date of first occurrence of documented disease progression
- Progression-free survival, defined as the time period from start of the treatment to the date of first occurrence of documented disease progression or death from any cause within 60 days from the last disease assessment or from cycle 1, day 1
- Overall survival, defined as the time period from enrollment to death from any cause.