Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003427
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD for the combination chemotherapy regimen of oxaliplatin plus irinotecan when both drugs are given once a week for four weeks followed by a two week rest in patients with metastatic gastrointestinal cancer II Evaluate the toxicities of this combination chemotherapy when administered in this manner III Determine the pharmacokinetics of platinum and irinotecan at the MTD for this combination chemotherapy in this patient population
OUTLINE This is a dose escalation study Patients receive oxaliplatin IV over 120 minutes immediately followed by irinotecan IV over 30 minutes weekly for 4 weeks days 1 8 15 and 22 Courses are repeated every 42 days Treatment continues in the absence of unacceptable side effects or disease progression Sequential dose escalation of oxaliplatin is followed by sequential dose escalation of irinotecan Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects Patients are followed approximately every 2-3 months
PROJECTED ACCRUAL A total of 2-36 patients will be accrued for this study within 18-36 months
OUTLINE This is a dose escalation study Patients receive oxaliplatin IV over 120 minutes immediately followed by irinotecan IV over 30 minutes weekly for 4 weeks days 1 8 15 and 22 Courses are repeated every 42 days Treatment continues in the absence of unacceptable side effects or disease progression Sequential dose escalation of oxaliplatin is followed by sequential dose escalation of irinotecan Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects Patients are followed approximately every 2-3 months
PROJECTED ACCRUAL A total of 2-36 patients will be accrued for this study within 18-36 months
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 |
|---|---|---|---|
| NCI-G98-1450 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066452 | REGISTRY | None | None |