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

Primary Purpose

Glioblastoma Multiforme (GBM), Glioblastoma, Glioma of Brain

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Capecitabine

Temozolomide

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme (GBM)

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
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).
Performance status, KPS < 70
Inability to swallow pills and capsules
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
Patients with renal insufficiency or hepatic insufficiency
Patients with coagulopathies
Women who are pregnant or lactating.

Sites / Locations

Lenox Hill Brain Tumor CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine amd Temozolomide

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

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)

OS will be calculated as the time from treatment initiation to the date of death.

Secondary Outcome Measures

Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)

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.

Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.

Full Information

NCT ID

NCT03213002

First Posted

July 6, 2017

Last Updated

October 17, 2022

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT03213002

Brief Title

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Acronym

CAPTEM

Official Title

Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 13, 2017 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme (GBM), Glioblastoma, Glioma of Brain, Glioblastoma, Adult, Brain Tumor, Brain Tumor, Primary, Brain Tumor Adult, Cancer, Brain Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine amd Temozolomide

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Capecitabine at 1500 mg/m2

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar

Intervention Description

Temozolomide at 150 mg/m2 - 200 mg/m2

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.

Time Frame

6 months

Title

Overall Survival (OS)

Description

OS will be calculated as the time from treatment initiation to the date of death.

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)

Description

Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.

Time Frame

6 months

Title

Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03.

Description

Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation. 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). Performance status, KPS < 70 Inability to swallow pills and capsules 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 Patients with renal insufficiency or hepatic insufficiency Patients with coagulopathies Women who are pregnant or lactating.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John Boockvar, MD

Phone

212-434-3900

jboockvar@northwell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tamika Wong, MPH

Phone

212-434-4836

twong4@northwell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Boockvar, MD

Organizational Affiliation

Lenox Hill Hospital-Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lenox Hill Brain Tumor Center

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamika Wong, MPH

Phone

212-434-4836

twong4@northwell.edu

First Name & Middle Initial & Last Name & Degree

John Boockvar, MD

First Name & Middle Initial & Last Name & Degree

David Langer, MD

First Name & Middle Initial & Last Name & Degree

Anuj Goenka, MD

First Name & Middle Initial & Last Name & Degree

Christopher Filippi, MD

First Name & Middle Initial & Last Name & Degree

Lalitha Anand, MD

First Name & Middle Initial & Last Name & Degree

Sherese Fralin, NP

First Name & Middle Initial & Last Name & Degree

Ashley Ray, NP

First Name & Middle Initial & Last Name & Degree

Tamika Wong, MPH

12. IPD Sharing Statement

Learn more about this trial

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

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