Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
- Determine the maximum tolerated dose of irinotecan hydrochloride administered
concurrently with whole-brain radiotherapy in patients with brain metastases from solid
tumors. (Phase I) (Phase I closed to accrual as of 4/15/05)
- Determine the toxicity of this regimen in these patients. (Phase I) (Phase I closed to
accrual as of 4/15/05)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Assess the neurocognitive function of these patients by Mini-Mental Status Examination.
OUTLINE: This is a phase I, dose-escalation study of irinotecan hydrochloride (phase I
closed to accrual as of 4/15/05) followed by a phase II study. Patients enrolled in phase II
are stratified according to cognitive dysfunction (yes vs no).
- Phase I (closed to accrual as of 4/15/05): Patients undergo whole-brain radiotherapy
(WBRT) once daily, 5 days a week, for 3 weeks (15 fractions). Patients also receive
irinotecan hydrochloride IV over 90 minutes on days 1, 8, and 15.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II (for patients enrolled after 4/15/05): Patients receive irinotecan
hydrochloride at the MTD and undergo concurrent WBRT as in phase I.
Patients complete the Mini-Mental Status Examination to assess neurocognitive function at
baseline, on the last day of radiotherapy, and periodically after completion of study
After completion of study therapy, patients are followed monthly for 3 months, at 6 months,
and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)
Allan Y. Chen, MD, PhD
University of California, Davis
United States: Federal Government
|University of California Davis Cancer Center||Sacramento, California 95817|