A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
- Determine the maximum tolerated dose of NB1011 in patients with
fluoropyrimidine-resistant metastatic or recurrent colorectal cancer.
- Determine the safety and toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive NB1011 IV over 1 hour on days 1-5. Treatment repeats every 28
days for up to 6 courses in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of NB1011 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity.
- Phase II: Additional patients receive NB1011 at the MTD as in phase I. Patients are
followed at day 30 and then for 5 months.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for the phase I portion of this
study. A total of 15-25 patients will be accrued for the phase II portion of this study.
Primary Purpose: Treatment
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|