Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

NCT03213002 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 17-0312
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• Overall Survival (OS)

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

  4 years

Secondary Outcomes (2)

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

  6 months

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

  6 months

Study Arms (1)

Capecitabine amd Temozolomide

EXPERIMENTAL

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; Drug: Temozolomide

Interventions

Capecitabine DRUG

Capecitabine at 1500 mg/m2

Also known as: Xeloda

Capecitabine amd Temozolomide

Temozolomide DRUG

Temozolomide at 150 mg/m2 - 200 mg/m2

Also known as: Temodar

Capecitabine amd Temozolomide

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Neoplasms

Interventions

Capecitabine; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; 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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles

Study Officials

• John Boockvar, MD

  Lenox Hill Hospital-Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Boockvar, MD

CONTACT

212-434-3900; jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836; twong4@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal INvesigator

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: June 13, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)