Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066391
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2003-08-06
Brief Title:
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of Irinotecan CPT 11 and Cisplatin CDDP in Metastatic or Locally Advanced Penile Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-09
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 irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Combining irinotecan with cisplatin may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer
PURPOSE Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer
Detailed Description:
OBJECTIVES
Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer
Determine the objective response rate and duration of response in patients treated with this regimen
Determine the acute side effects of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive irinotecan IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 1-3 hours on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients not undergoing local treatment receive up to 8 courses Patients planning to undergo surgery receive up to 4 courses
Patients are followed every 8 weeks until disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 13-28 patients will be accrued for this study
Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer
Determine the objective response rate and duration of response in patients treated with this regimen
Determine the acute side effects of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive irinotecan IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 1-3 hours on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients not undergoing local treatment receive up to 8 courses Patients planning to undergo surgery receive up to 4 courses
Patients are followed every 8 weeks until disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 13-28 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 |
|---|---|---|---|
| EORTC-30992 | None | None | None |