Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005860
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2000-06-02
Brief Title:
Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity
Status:
COMPLETED
Status Verified Date:
2002-05
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 with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum
PURPOSE Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer confined to the peritoneal cavity
Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population
OUTLINE This is a dose escalation study of oxaliplatin
Patients receive intraperitoneal IP oxaliplatin over 1 hour on day 1 every 2 weeks for 2 courses
Beginning at course 3 patients receive oxaliplatin with floxuridine and leucovorin calcium IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Patients with complete surgical resection of disease receive a total of 6 courses of combination chemotherapy
Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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 toxicity
PROJECTED ACCRUAL A total of 3-40 patients will be accrued for this study
Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer confined to the peritoneal cavity
Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population
OUTLINE This is a dose escalation study of oxaliplatin
Patients receive intraperitoneal IP oxaliplatin over 1 hour on day 1 every 2 weeks for 2 courses
Beginning at course 3 patients receive oxaliplatin with floxuridine and leucovorin calcium IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Patients with complete surgical resection of disease receive a total of 6 courses of combination chemotherapy
Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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 toxicity
PROJECTED ACCRUAL A total of 3-40 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 |
|---|---|---|---|
| NCI-T99-0107 | None | None | None |
| MSKCC-99100 | None | None | None |