Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027729
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2001-12-07
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III 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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2032 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069061 | REGISTRY | None | None |
| MEDIMMUNE-MI-CP068 | None | None | None |