Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016874
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-06-06
Brief Title:
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic 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 In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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 cisplatin and paclitaxel in treating patients who have advanced or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of combining 3-AP cisplatin and paclitaxel in treating patients who have advanced or metastatic cancer
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of 3-AP cisplatin and paclitaxel in patients with advanced or metastatic cancer
Determine the toxic effects of this regimen in these patients
Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients
Determine the pharmacokinetic parameters of this regimen in these patients
Determine the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 1 additional course of therapy after documented CR Patients with partial response or stable disease may receive therapy for up to 6 months
Cohorts of 1-6 patients receive escalating doses of 3-AP paclitaxel and 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 Approximately 25-30 patients will be accrued for this study
Determine the safety and tolerability of 3-AP cisplatin and paclitaxel in patients with advanced or metastatic cancer
Determine the toxic effects of this regimen in these patients
Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients
Determine the pharmacokinetic parameters of this regimen in these patients
Determine the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 1 additional course of therapy after documented CR Patients with partial response or stable disease may receive therapy for up to 6 months
Cohorts of 1-6 patients receive escalating doses of 3-AP paclitaxel and 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 Approximately 25-30 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-V01-1658 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068591 | REGISTRY | None | None |
| AECM-1200012380 | None | None | None |