A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
|ClinicalTrials.gov Identifier: NCT01118377|
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : December 3, 2013
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Brainstem Glioma||Drug: Capecitabine Radiation: Radiation therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||April 2013|
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.
Capecitabine was supplied as film-coated tablets.
Other Name: XelodaRadiation: Radiation therapy
Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.
- Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ]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.
- Overall Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118377
|United States, California|
|San Francisco, California, United States, 94143-0780|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20010|
|United States, Illinois|
|Chicago, Illinois, United States, 60614|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Pittsburgh, Pennsylvania, United States, 15261|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38015|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||Clinical Trials||Hoffmann-La Roche|