ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM (CAPTEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03213002
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
John A. Boockvar, Northwell Health

Brief Summary:

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

Detailed Description:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: Capecitabine
Capecitabine at 1500 mg/m2
Other Name: Xeloda

Drug: Temozolomide
Temozolomide at 150 mg/m2 - 200 mg/m2
Other Name: Temodar




Primary Outcome Measures :
  1. 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.

  2. Overall Survival (OS) [ Time Frame: 4 years ]
    OS will be calculated as the time from treatment initiation to the date of death.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: John Boockvar, MD 212-434-3900 jboockvar@northwell.edu
Contact: Tamika Wong, MPH 212-434-4836 twong4@northwell.edu

Locations
United States, New York
Lenox Hill Brain Tumor Center Recruiting
New York, New York, United States, 10075
Contact: Tamika Wong, MPH    212-434-4836    twong4@northwell.edu   
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         
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: John Boockvar, MD Lenox Hill Hospital-Northwell Health

Responsible Party: John A. Boockvar, Prinicpal INvesigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03213002     History of Changes
Other Study ID Numbers: 17-0312
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Capecitabine
Temozolomide
Dacarbazine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents