Combining capecitabine and temozolomide for newly diagnosed glioblastoma
Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)
This study is testing if combining two cancer drugs, capecitabine and temozolomide, can help people with newly diagnosed glioblastoma live longer and feel better compared to using temozolomide alone.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03213002 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of administering capecitabine alongside temozolomide for patients with newly diagnosed glioblastoma multiforme (GBM). Participants will receive a dosage of 1500 mg/m2 of capecitabine after completing radiation therapy and starting their monthly regimen of temozolomide. The goal is to determine if this combination improves treatment response duration compared to temozolomide alone, which is the current standard of care. The trial aims to enhance survival rates and quality of life for patients suffering from this aggressive brain tumor.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 74 with newly diagnosed glioblastoma multiforme who have completed initial radiation therapy and have not yet started maintenance temozolomide.
Not a fit: Patients who have previously received chemotherapy with capecitabine or temozolomide for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and longer periods of treatment response for patients with glioblastoma.
How similar studies have performed: While the combination of capecitabine and temozolomide is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Lenox Hill Brain Tumor Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: John Boockvar, MD — Lenox Hill Hospital-Northwell Health
- Study coordinator: John Boockvar, MD
- Email: jboockvar@northwell.edu
- Phone: 212-434-3900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.