Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072332
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2003-11-04
Brief Title:
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose Escalation Study of Edotecarin PHA-782615 and Cisplatin in Adult Patients With AdvancedMetastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-12
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 such as edotecarin and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Combining edotecarin with cisplatin may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of edotecarin when administered with cisplatin administered in 2 different schedules in patients with advanced or metastatic solid tumors
Secondary
Determine the safety profile of this regimen in these patients
Determine the plasma pharmacokinetics of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is an open-label multicenter dose-escalation study of edotecarin Patients are assigned to 1 of 2 schedules
Schedule A Patients receive cisplatin IV over 30 minutes and edotecarin IV over 1 hour on days 1 and 8
Schedule B Patients receive cisplatin IV over 2 hours and edotecarin IV over 1 hour on day 1
In both schedules courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each schedule receive escalating doses of edotecarin 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 Once the MTD is determined 10 additional patients with metastatic esophageal or gastric cancer receive treatment as above at the MTD
Patients are followed every 2 months for 1 year or until disease progression
PROJECTED ACCRUAL A maximum of 80 patients 40 per schedule will be accrued for this study
Primary
Determine the maximum tolerated dose and recommended phase II dose of edotecarin when administered with cisplatin administered in 2 different schedules in patients with advanced or metastatic solid tumors
Secondary
Determine the safety profile of this regimen in these patients
Determine the plasma pharmacokinetics of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is an open-label multicenter dose-escalation study of edotecarin Patients are assigned to 1 of 2 schedules
Schedule A Patients receive cisplatin IV over 30 minutes and edotecarin IV over 1 hour on days 1 and 8
Schedule B Patients receive cisplatin IV over 2 hours and edotecarin IV over 1 hour on day 1
In both schedules courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each schedule receive escalating doses of edotecarin 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 Once the MTD is determined 10 additional patients with metastatic esophageal or gastric cancer receive treatment as above at the MTD
Patients are followed every 2 months for 1 year or until disease progression
PROJECTED ACCRUAL A maximum of 80 patients 40 per schedule will be accrued for 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 |
|---|---|---|---|
| PHARMACIA-EDOAES-2730-001 | None | None | None |
| MSKCC-03070 | None | None | None |