A Phase I Study of XL119 (Rebeccamycin Analogue) in Combination With Oxaliplatin in Patients With Refractory Solid Tumors
I. To determine the maximum tolerated dose of XL119 given in conjunction with oxaliplatin.
II.To determine the dose limiting toxicities of this combination. III. To determine the
pharmacokinetics of these 2 agents when given in combination.
OUTLINE: This is a dose-escalation study.
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2
hours on day 5. Courses repeat every 21 days in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and oxaliplatin
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. At
least 6 patients are treated at the MTD.
Patients are followed annually for survival.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose defined as the highest dose tested in which none or only one patient experienced dose limiting toxicities as measured by Common Toxicity Criteria
Case Western Reserve University
United States: Food and Drug Administration
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