Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083122
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2004-05-14
Brief Title:
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
Status:
COMPLETED
Status Verified Date:
2013-04
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 II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer Drugs used in chemotherapy such as cisplatin and flavopiridol 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:
OBJECTIVES
I Determine the response rate time to progression and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol
II Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are accrued to two separate groups Group 2 closed to accrual as of 31006
GROUP 1 Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
GROUP 2 Closed to accrual as of 31006 Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for up to 3 years
I Determine the response rate time to progression and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol
II Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are accrued to two separate groups Group 2 closed to accrual as of 31006
GROUP 1 Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
GROUP 2 Closed to accrual as of 31006 Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for up to 3 years
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 |
|---|---|---|---|
| P30CA015083 | NIH | CTEP | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2009-00029 | REGISTRY | None | None |
| CDR0000363562 | None | None | None |
| MC0261 | OTHER | None | None |
| 5876 | OTHER | None | None |
| N01CM62205 | NIH | None | None |