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
Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.
Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
Single group
Capecitabine
DrugCapecitabine at 1500 mg/m2
Temozolomide
DrugTemozolomide at 150 mg/m2 - 200 mg/m2
Progression-free survival (PFS)
PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Overall Survival (OS)
OS will be calculated as the time from treatment initiation to the date of death.
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03.
Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.
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