A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

This study has been completed.
Sponsor:
Collaborator:
Pediatric Brain Tumor Consortium
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01118377
First received: April 15, 2010
Last updated: February 4, 2014
Last verified: February 2014

April 15, 2010
February 4, 2014
May 2007
January 2013   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.
Progression-free survival: MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01118377 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.
  • Percentage of Participants With a Tumor Response [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
    Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.
  • Overall survival distribution: OS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety Profile: Adverse Events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of capecitabine [Xeloda] and its metabolites [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Safety: Laboratory Parameters [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.

The open-label phase 2 study NO21125 (NCT01118377) evaluated the progression-free survival, safety, and pharmacokinetics of capecitabine (Xeloda®) rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. There were 2 phases to the study: A 9-week radiation phase, followed by a 2-week rest period, and a 9-week post-radiation phase. In the radiation phase, capecitabine 650 mg/m^2 was administered orally twice daily for 9 weeks. Concomitantly, patients received radiation therapy (180 cGy fractions) 5 days a week for a total target dose of 56 Gy. During the 9-week post-radiation phase of the study, capecitabine 1250 mg/m^2 was administered orally twice daily for 14 days followed by a 7-day rest period. This cycle of 14 days treatment followed by 7 days rest was repeated 2 additional times. The dose could be adjusted according to toxicity and body surface area.

The single-arm phase 1 study NO18517 (NCT00532948) assessed the maximum tolerated dose and dose-limiting toxicities of capecitabine (Xeloda®) administered concurrently with radiation therapy in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Patients in the phase 1 study NO18517 who were diagnosed with intrinsic brainstem glioma and who were treated at the established maximum tolerated dose of capecitabine 650 mg/m^2/dose twice a day were included in the analyses of the phase 2 study NO21125.

The efficacy and safety results of study NO21125 are reported below.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brainstem Glioma
  • Drug: Capecitabine
    Capecitabine was supplied as film-coated tablets.
    Other Name: Xeloda
  • Radiation: Radiation therapy
    Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.
Experimental: Capecitabine + radiation therapy
Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Interventions:
  • Drug: Capecitabine
  • Radiation: Radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric and adolescent patients ≥ 3 to < 18 years of age.
  • Patients must have a newly diagnosed non-disseminated intrinsic infiltrating brainstem glioma.
  • Karnofsky Performance Scale (if > 16 years of age) or Lansky Performance Score (if ≤ 16 years of age) ≥ 50% assessed within 2 weeks prior to registration to study.
  • Patients must not have received any prior chemotherapy or bone marrow transplant for the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
  • Adequate organ function.

Exclusion Criteria:

  • Patients receiving any other anticancer or experimental drug therapy.
  • Patients with uncontrolled infection.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Both
3 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118377
NO21125, PBTC-030
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Pediatric Brain Tumor Consortium
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP