Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM (CAPTEM)
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|ClinicalTrials.gov Identifier: NCT03213002|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme (GBM) Glioblastoma Glioma of Brain Glioblastoma, Adult Brain Tumor Brain Tumor, Primary Brain Tumor Adult Cancer Brain Cancer||Drug: Capecitabine Drug: Temozolomide||Phase 1 Phase 2|
There were an estimated 22,000 new cases of brain cancers in 2015 in the United States, and 15,000 deaths (Howlader et al., 2014). Glioblastoma (WHO IV), and Anaplastic Astrocytoma (WHO III), are the most common brain cancers, respectively, representing over 70% of all malignant gliomas (ABTA, 2015).
Though rare, there is no cure, and the prognosis for these tumors is poor. Survival at 5 years for all CNS cancers is approximately 33.3 % (Howlader et al., 2014). For GBM, the most lethal of the tumors, with the current standard of care median survival is 14.6 months (Walid, 2008). Relative survival with GBM at five years is approximately only 5% (Ostrom et al. CBTRUS 2014).
For newly diagnosed tumors, the current standard of care recommends a multi-modal approach with surgery to remove the tumor, when possible, followed by 6 weeks of radiation and a concurrent daily dose of temozolomide (Stupp et al. 2005). This is known as the Stupp protocol (Stupp et al. 2005). Patients then have a one-month rest period with no treatment, followed by "maintenance" temozolomide, given five days out of every 28 days, for a minimum of six months. Some providers keep patients on temozolomide beyond 6 months, or until disease progression.
Therefore, more therapies are needed to help improve survival, reduce time to recurrence and improve quality of life for these patients. This trial proposes to improve the current standard of care by enhancing the efficacy of an active drug temozolomide, currently used for treatment of GBM.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)|
|Actual Study Start Date :||June 13, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Capecitabine amd Temozolomide
Oral Capecitabine at 1500 mg/m2 divided into twice daily dosing, taken on days 1-14, and Temozolomide at 150 mg/m2 - 200 mg/m2 divided into twice daily dosing, taken on days 10-14; days 15-28 off.
Capecitabine at 1500 mg/m2
Other Name: Xeloda
Temozolomide at 150 mg/m2 - 200 mg/m2
Other Name: Temodar
- Progression-free survival (PFS) [ Time Frame: 6 months ]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) [ Time Frame: 4 years ]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) [ Time Frame: 6 months ]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. [ Time Frame: 6 months ]Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213002
|Contact: John Boockvar, MDemail@example.com|
|Contact: Tamika Wong, MPHfirstname.lastname@example.org|
|United States, New York|
|Lenox Hill Brain Tumor Center||Recruiting|
|New York, New York, United States, 10075|
|Contact: Tamika Wong, MPH 212-434-4836 email@example.com|
|Principal Investigator: John Boockvar, MD|
|Sub-Investigator: David Langer, MD|
|Sub-Investigator: Anuj Goenka, MD|
|Sub-Investigator: Christopher Filippi, MD|
|Sub-Investigator: Lalitha Anand, MD|
|Sub-Investigator: Sherese Fralin, NP|
|Sub-Investigator: Ashley Ray, NP|
|Sub-Investigator: Tamika Wong, MPH|
|Principal Investigator:||John Boockvar, MD||Lenox Hill Hospital-Northwell Health|