Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119236
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2005-07-12
Brief Title:
17-AAG and Irinotecan in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Labeled Non-Randomized Phase I Study of 17-N-allylamino-17-demethoxy Geldanamycin 17AAG Administered With Irinotecan CPT-11 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors Drugs used in chemotherapy such as 17-AAG and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of combined 17AAG and irinotecan given weekly for two weeks in a 21-day cycle that can be used for future phase II studies
SECONDARY OBJECTIVES
I To explore the effects of the combination on the expression of Hsp90 client proteins in peripheral mononuclear cells and tumor tissues Tumor biopsies will be performed before and after 17AAG treatment in 12 patients at the MTD Expanded Cohort only
II To investigate the clinical pharmacokinetics of intravenous 17AAG irinotecan and their metabolites in this combination
III To obtain preliminary data on the therapeutic activity of 17AAG in combination with irinotecan in patients with advanced solid tumors
IV To obtain preliminary result in the relationship between tumor response and p53-status
OUTLINE This is an open-label non-randomized dose-escalation study
Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2 hours on days 1 and 8 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable or improved disease after course 2 may receive additional courses of treatment
NOTE 17-AAG is administered on days 2 and 8 during course 2 for patients treated at non-maximum tolerated doses MTD dose-escalation portion and on day 8 only during course 1 for patients treated at the MTD expanded cohortCohorts of 3-6 patients receive escalating doses of 17-AAG and irinotecan until the 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 An additional 12 patients are treated at the MTD
I To determine the maximum tolerated dose MTD of combined 17AAG and irinotecan given weekly for two weeks in a 21-day cycle that can be used for future phase II studies
SECONDARY OBJECTIVES
I To explore the effects of the combination on the expression of Hsp90 client proteins in peripheral mononuclear cells and tumor tissues Tumor biopsies will be performed before and after 17AAG treatment in 12 patients at the MTD Expanded Cohort only
II To investigate the clinical pharmacokinetics of intravenous 17AAG irinotecan and their metabolites in this combination
III To obtain preliminary data on the therapeutic activity of 17AAG in combination with irinotecan in patients with advanced solid tumors
IV To obtain preliminary result in the relationship between tumor response and p53-status
OUTLINE This is an open-label non-randomized dose-escalation study
Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2 hours on days 1 and 8 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable or improved disease after course 2 may receive additional courses of treatment
NOTE 17-AAG is administered on days 2 and 8 during course 2 for patients treated at non-maximum tolerated doses MTD dose-escalation portion and on day 8 only during course 1 for patients treated at the MTD expanded cohortCohorts of 3-6 patients receive escalating doses of 17-AAG and irinotecan until the 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 An additional 12 patients are treated at the MTD
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 |
|---|---|---|---|
| 05-017 | None | None | None |
| MSKCC-IRB-05017 | None | None | None |
| NCI-7009 | None | None | None |
| CDR0000434501 | None | None | None |
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |