Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053833
Status:
TERMINATED
Last Update Posted:
2013-11-08
First Post:
2003-02-05
Brief Title:
S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0025 Phase II Trial Of Irinotecan CAMPTOSAR For Patients With Platinum And Taxane Refractory Ovarian Peritoneal Or Fallopian Tube Cancer
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
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
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial primary peritoneal or fallopian tube cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial primary peritoneal or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial primary peritoneal or fallopian tube cancer treated with irinotecan
Determine the progression-free and overall survival of patients treated with this drug
Evaluate the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE Patients receive irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial primary peritoneal or fallopian tube cancer treated with irinotecan
Determine the progression-free and overall survival of patients treated with this drug
Evaluate the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE Patients receive irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-40 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 |
|---|---|---|---|
| S0025 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |