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 AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor. * Determine the safety and tolerance of this drug in these patients. * Assess the pharmacokinetics of this drug in these patients. * Document any antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of AG2037 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. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
22
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.