Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

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Brief Title

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Official Title

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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival (PFS)

Secondary Outcome

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

Condition

Glioblastoma Multiforme (GBM)

Intervention

Capecitabine

Study Arms / Comparison Groups

 Capecitabine amd Temozolomide
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

67

Start Date

June 13, 2017

Completion Date

June 2021

Primary Completion Date

June 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - 74 Years

Accepts Healthy Volunteers

No

Contacts

John Boockvar, MD, 212-434-3900, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03213002

Organization ID

17-0312


Responsible Party

Principal Investigator

Study Sponsor

Northwell Health


Study Sponsor

John Boockvar, MD, Principal Investigator, Lenox Hill Hospital-Northwell Health


Verification Date

November 2019