Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081276
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-04-07
Brief Title:
3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation Of Triapine NCI-Supplied Agent NSC 663249 IND 68338 In Combination With Cisplatin Commercially Available NSC 119875 In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
Status:
COMPLETED
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:
Drugs used in chemotherapy such as 3-AP and cisplatin 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 This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival in patients treated with this regimen
II Determine the effects of prognostic variables including initial performance status age and mucinous or clear cell histology in these patients
OUTLINE This is a non-randomized study
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 23-48 patients will be accrued for this study within 13 months
I Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival in patients treated with this regimen
II Determine the effects of prognostic variables including initial performance status age and mucinous or clear cell histology in these patients
OUTLINE This is a non-randomized study
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 23-48 patients will be accrued for this study within 13 months
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 |
|---|---|---|---|
| GOG-0126O | None | None | None |
| U10CA027469 | NIH | None | None |
| CDR0000360854 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA027469 |