Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087217
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2004-07-08
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin 17-AAG in Combination With Paclitaxel in Advanced Solid Malignancies
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:
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG when administered with paclitaxel in patients with metastatic or unresectable solid malignancy
II Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients
III Determine the pharmacokinetics of this regimen in these patients IV Determine tumor response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG Patients receive 17-AAG IV over 1 hour on days 1 4 8 11 15 and 18 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
NOTE 17-AAG is not administered on day 1 of course 1 Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 6-12 patients are treated at the recommended phase II dose
I Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG when administered with paclitaxel in patients with metastatic or unresectable solid malignancy
II Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients
III Determine the pharmacokinetics of this regimen in these patients IV Determine tumor response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG Patients receive 17-AAG IV over 1 hour on days 1 4 8 11 15 and 18 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
NOTE 17-AAG is not administered on day 1 of course 1 Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 6-12 patients are treated at the recommended phase II dose
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 |
|---|---|---|---|
| CDR0000373824 | REGISTRY | PDQ Physician data Query | httpsreporternihgovquickSearchU01CA062502 |
| PCI-03-152 | None | None | None |
| U01CA099168 | NIH | None | None |
| U01CA062502 | NIH | None | None |