NCT03213002RecruitingPhase 1/2
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- First submitted
- 6 Jul 2017
- Start date
- 13 Jun 2017
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Northwell Health
- Diseases
- Glioblastoma
- NCT number
- NCT03213002
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 67
- From 13 Jun 2017 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
- Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
- Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
- Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
Other illness
- 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.
- 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)
- 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).
- Patients with renal insufficiency or hepatic insufficiency
Other
- Performance status, KPS \< 70
- Inability to swallow pills and capsules
- Patients with coagulopathies
- Women who are pregnant or lactating.
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lenox Hill Brain Tumor Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.