Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Launched by NORTHWELL HEALTH · Jul 6, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with newly diagnosed glioblastoma multiforme (GBM), a type of aggressive brain cancer. The researchers want to see if combining two oral medications, capecitabine and temozolomide, can be safe and more effective than using temozolomide alone, which is currently the standard treatment. Capecitabine is already used for other cancers, and in this trial, participants will take a specific dose of capecitabine after completing radiation therapy and while starting temozolomide.

To participate, individuals must be between 18 and 74 years old, have a confirmed diagnosis of GBM, and have recently completed the initial phase of standard treatment. They should also be in reasonably good health and able to swallow pills. Participants will be closely monitored for safety and how well they respond to the treatment. It’s important for potential participants to discuss their health conditions with their doctors to see if they meet the criteria for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be capable of giving informed consent.
• • 2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
• • 3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
• • 4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
• • 5. Have a life expectancy \> 3 months
• • 6. Be between the ages of 18 to 74
• • 7. Have a performance status KPS 70 or greater
• • 8. Be able to swallow pills and capsules
• • 9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings
• • 10. Have adequate bone marrow function, liver function and renal function before commencing therapy
• Exclusion Criteria:
• • 1. 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.
• • 2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
• • 3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
• • 4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
• • 5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).
• • 6. Performance status, KPS \< 70
• • 7. Inability to swallow pills and capsules
• • 8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
• • 9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
• • 10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
• • 11. Patients with renal insufficiency or hepatic insufficiency
• • 12. Patients with coagulopathies
• • 13. Women who are pregnant or lactating.