Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005078
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2000-04-06
Brief Title:
Tirapazamine Carboplatin and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase I Dose Escalation Study of Tirapazamine NSC 130181 in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-06
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 tirapazamine carboplatin and paclitaxel in treating patients who have advanced malignant solid tumors
PURPOSE Phase I trial to study the effectiveness of combining tirapazamine carboplatin and paclitaxel in treating patients who have advanced malignant solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of tirapazamine in combination with carboplatin and paclitaxel in patients with advanced solid tumors who have or have not received prior chemotherapy
Assess the toxicity and preliminary efficacy of this regimen in these patients
Determine the pharmacokinetic profile of this regimen in these patients
Investigate potential predictors of response by studying patient tissue specimens after receiving this regimen
OUTLINE This is a dose-escalation study of tirapazamine Patients are stratified according to prior chemotherapy status previously untreated vs previously treated
Patients receive tirapazamine IV over 2 hours paclitaxel IV over 3 hours and carboplatin IV over 30 minutes Treatment continues every 21 days for a maximum of 8 courses in the absence of unacceptable toxicity or disease progression Some patients may continue therapy in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tirapazamine 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 An additional 12 patients in the previously untreated stratum are treated at the MTD
Patients are followed indefinitely
PROJECTED ACCRUAL A total of 36-68 patients 18-34 per stratum will be accrued for this study within 12-18 months
Determine the maximum tolerated dose of tirapazamine in combination with carboplatin and paclitaxel in patients with advanced solid tumors who have or have not received prior chemotherapy
Assess the toxicity and preliminary efficacy of this regimen in these patients
Determine the pharmacokinetic profile of this regimen in these patients
Investigate potential predictors of response by studying patient tissue specimens after receiving this regimen
OUTLINE This is a dose-escalation study of tirapazamine Patients are stratified according to prior chemotherapy status previously untreated vs previously treated
Patients receive tirapazamine IV over 2 hours paclitaxel IV over 3 hours and carboplatin IV over 30 minutes Treatment continues every 21 days for a maximum of 8 courses in the absence of unacceptable toxicity or disease progression Some patients may continue therapy in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tirapazamine 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 An additional 12 patients in the previously untreated stratum are treated at the MTD
Patients are followed indefinitely
PROJECTED ACCRUAL A total of 36-68 patients 18-34 per stratum will be accrued for this study within 12-18 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 |
|---|---|---|---|
| CDR0000067685 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| U01CA062505 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-22 | None | None | None |
| CHNMC-IRB-99139 | None | None | None |
| NCI-T99-0068 | None | None | None |