Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024323
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-09-13
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone 3-AP Triapine Administered Daily x 5 in Combination With Cisplatin
Status:
COMPLETED
Status Verified Date:
2002-11
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer
Determine the toxic effects of this regimen in these patients
Determine the antitumor responses in patients treated with this regimen
OUTLINE This is a dose-escalation study of cisplatin
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer
Determine the toxic effects of this regimen in these patients
Determine the antitumor responses in patients treated with this regimen
OUTLINE This is a dose-escalation study of cisplatin
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 15-25 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 |
|---|---|---|---|
| NCI-V01-1668 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068918 | REGISTRY | None | None |