Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients
who have advanced solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan
liposome in patients with advanced solid tumors. II. Assess the toxicity and pharmacokinetics
of this treatment regimen in this patient population. III. Assess the response to this
regimen by patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome
(NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks. Treatment
continues for up to 6 courses in the absence of unacceptable toxicity or disease progression.
The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Patients are followed at 4 weeks and every 3 months for 1
year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15
months.
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