Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047047
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-10-03
Brief Title:
Tanespimycin Gemcitabine Hydrochloride and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of Gemcitabine 17-Allylaminogeldanamycin 17-AAG And Cisplatin In Advanced Solid Tumor Patients
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 studies the side effects best way to give and best doses of tanespimycin with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced solid tumors Drugs used in chemotherapy such as tanespimycin gemcitabine hydrochloride and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Using more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximally tolerated dose MTD of 17-AAG tanespimycin when given on days 1 and 8 of every 3 weeks cycle in combination with Gemzar gemcitabine hydrochloride and CDDP cisplatin cohorts A B and E
II To determine the MTD of 17-AAG plus Gemzar when Gemzar is given on days 1 and 8 and 17-AAG is given on days 2 and 9 every 3 weeks cohort C
III To determine the MTD of 17-AAG plus CDDP when given on days 1 and 8 every 3 weeks cohort D
IV To define the dose-limiting toxicity of 17-AAG when used in combination with Gemzar and CDDP
V To assess the effect of 17-AAG on surrogate markers when used in combination with Gemzar and CDDP
VI To report any responses observed
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 3 treatment cohorts
Cohort A closed to accrual as of 3204 Patients receive escalating doses of gemcitabine hydrochloride intravenously IV over 30 minutes tanespimycin IV over 1 hour and cisplatin IV over 2 hours on days 1 and 8 NOTE The maximum tolerated dose MTD of this 3-drug combination has been determined as of 3204
Cohort B closed to accrual as of 3205 Patients receive gemcitabine hydrochloride IV over 30 minutes tanespimycin IV over 1 hour and cisplatin IV over 2 hours on days 1 and 8
Cohort C Patients receive gemcitabine hydrochloride IV over 30 minutes and tanespimycin IV over 1-2 hours on days 2 and 9
Cohort D Patients receive cisplatin IV over 2 hours and tanespimycin IV over 1-2 hours on days 1 and 8
Cohort E Patients receive gemcitabine hydrochloride tanespimycin and cisplatin as in cohort B
In all cohorts courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 3 months
NOTE Gemcitabine hydrochloride and cisplatin dosage is constant while 17-AAG is escalated in cohorts B C and D
NOTE Gemcitabine hydrochloride dosage is constant 17-AAG is started at a higher dose level than all other cohorts and cisplatin dosage is escalated in cohort E
I To determine the maximally tolerated dose MTD of 17-AAG tanespimycin when given on days 1 and 8 of every 3 weeks cycle in combination with Gemzar gemcitabine hydrochloride and CDDP cisplatin cohorts A B and E
II To determine the MTD of 17-AAG plus Gemzar when Gemzar is given on days 1 and 8 and 17-AAG is given on days 2 and 9 every 3 weeks cohort C
III To determine the MTD of 17-AAG plus CDDP when given on days 1 and 8 every 3 weeks cohort D
IV To define the dose-limiting toxicity of 17-AAG when used in combination with Gemzar and CDDP
V To assess the effect of 17-AAG on surrogate markers when used in combination with Gemzar and CDDP
VI To report any responses observed
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 3 treatment cohorts
Cohort A closed to accrual as of 3204 Patients receive escalating doses of gemcitabine hydrochloride intravenously IV over 30 minutes tanespimycin IV over 1 hour and cisplatin IV over 2 hours on days 1 and 8 NOTE The maximum tolerated dose MTD of this 3-drug combination has been determined as of 3204
Cohort B closed to accrual as of 3205 Patients receive gemcitabine hydrochloride IV over 30 minutes tanespimycin IV over 1 hour and cisplatin IV over 2 hours on days 1 and 8
Cohort C Patients receive gemcitabine hydrochloride IV over 30 minutes and tanespimycin IV over 1-2 hours on days 2 and 9
Cohort D Patients receive cisplatin IV over 2 hours and tanespimycin IV over 1-2 hours on days 1 and 8
Cohort E Patients receive gemcitabine hydrochloride tanespimycin and cisplatin as in cohort B
In all cohorts courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 3 months
NOTE Gemcitabine hydrochloride and cisplatin dosage is constant while 17-AAG is escalated in cohorts B C and D
NOTE Gemcitabine hydrochloride dosage is constant 17-AAG is started at a higher dose level than all other cohorts and cisplatin dosage is escalated in cohort E
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 |
|---|---|---|---|
| U01CA069912 | NIH | None | httpsreporternihgovquickSearchU01CA069912 |
| MC0111 | None | None | None |
| MAYO-MC0111 | None | None | None |
| CDR0000257247 | None | None | None |
| NCI-5291 | None | None | None |