Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086983
Status:
TERMINATED
Last Update Posted:
2013-01-10
First Post:
2004-07-08
Brief Title:
Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of XL119 Rebeccamycin Analogue in Combination With Oxaliplatin in Patients With Refractory Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of rebeccamycin analog and oxaliplatin in treating patients with refractory solid tumors Drugs used in chemotherapy such as rebeccamycin analog and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of XL119 given in conjunction with oxaliplatin
IITo determine the dose limiting toxicities of this combination III To determine the pharmacokinetics of these 2 agents when given in combination
OUTLINE This is a dose-escalation study
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2 hours on day 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and 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 At least 6 patients are treated at the MTD
Patients are followed annually for survival
I To determine the maximum tolerated dose of XL119 given in conjunction with oxaliplatin
IITo determine the dose limiting toxicities of this combination III To determine the pharmacokinetics of these 2 agents when given in combination
OUTLINE This is a dose-escalation study
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2 hours on day 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and 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 At least 6 patients are treated at the MTD
Patients are followed annually for survival
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |
| CASE 4Y03 | None | None | None |