Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081237
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2004-04-07
Brief Title:
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal 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 OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining OSI-7904L with oxaliplatin may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer
PURPOSE This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer
Determine the maximum tolerated dose of this regimen in these patients
Determine a safe dose for this regimen in these patients
Secondary
Determine the pharmacokinetic profile of this regimen in these patients
Determine the safety profile of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter open-label dose-escalation study
Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin 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 A maximum of 12 patients receive treatment at the MTD
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer
Determine the maximum tolerated dose of this regimen in these patients
Determine a safe dose for this regimen in these patients
Secondary
Determine the pharmacokinetic profile of this regimen in these patients
Determine the safety profile of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter open-label dose-escalation study
Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin 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 A maximum of 12 patients receive treatment at the MTD
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OSI-EORTC-16033 | None | None | None |
| EORTC-16033 | None | None | None |