Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058253
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2003-04-07
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 17-N-Allylamino-17-Demethoxy Geldanamycin 17-AAG NSC 330507 in Combination With Docetaxel in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors Drugs used in chemotherapy such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin 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
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG administered with docetaxel in patients with progressive metastatic prostate cancer or other progressive metastatic or unresectable solid tumors
II Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Group 2 Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per group 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 Up to 20 additional patients 10 per group are treated at the MTD
Patients are followed every 2-3 months
I Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG administered with docetaxel in patients with progressive metastatic prostate cancer or other progressive metastatic or unresectable solid tumors
II Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Group 2 Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per group 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 Up to 20 additional patients 10 per group are treated at the MTD
Patients are followed every 2-3 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 |
|---|---|---|---|
| U01CA069856 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069856 |
| NCI-2012-01436 | REGISTRY | None | None |
| NCI-5878 | None | None | None |
| CDR0000287199 | None | None | None |
| MSKCC-03006 | None | None | None |
| 03-006 | OTHER | None | None |
| 5878 | OTHER | None | None |
| P30CA008748 | NIH | None | None |