Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)
The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.
• Be capable of giving informed consent.
• Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
• Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
• Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
• Have a life expectancy \> 3 months
• Be between the ages of 18 to 74
• Have a performance status KPS 70 or greater
• Be able to swallow pills and capsules
• Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings
⁃ Have adequate bone marrow function, liver function and renal function before commencing therapy