Phase I/II Study of MEDI-522, A Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
OBJECTIVES:
- Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in
patients with irinotecan-refractory advanced colorectal cancer.
- Determine the safety and tolerance of this drug in these patients.
- Determine any antitumor activity of this drug in these patients.
- Determine the objective response rate, response duration, and time to progression in
patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes once weekly on
weeks 1-52 in the absence of disease progression or unacceptable toxicity. Patients with
responding disease may continue therapy.
Cohort of 4-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Once the MTD
is determined, additional patients are treated at that dose in the phase II portion of the
study.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for phase I of this study and a
total of 40 patients will be accrued for phase II of this study.
Interventional
Primary Purpose: Treatment
Leonard B. Saltz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
01-078
NCT00027729
June 2001
November 2004
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |