Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor
OBJECTIVES: I. Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors. II. Assess the safety and tolerability of this therapy in these patients. III. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients. IV. Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy. V. Determine a recommended phase II dose of SU6668 for future clinical studies. OUTLINE: This is a dose-escalation study. Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more. Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
M D Anderson Cancer Center
Houston, Texas, United States
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0
Time frame: Up to 2 years
Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0
Time frame: Up to 4 weeks
Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 2 years
Angiogenic surrogate measures in terms of change in cytokines over time
A mixed-effects analysis of variance (ANOVA) model will be used, and a fixed-effects model in which the same polynomial is fit for each patient will be used.
Time frame: Days 8, 15, and 22
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