Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT00611468
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors
Sponsor:
Accelerated Community Oncology Research Network
Organization:
Study Overview
Official Title:
A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-08
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:
The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.
Detailed Description:
The primary objectives of this trial include:
* To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
* To define the dosage-limiting toxicities (DLT) of this combination.
* To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib
The secondary objectives include:
* To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
* To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics
* To measure the frequency of UGT genotypes in peripheral blood samples
* To evaluate the objective response rate using the RECIST criteria.
* To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
* To define the dosage-limiting toxicities (DLT) of this combination.
* To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib
The secondary objectives include:
* To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
* To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics
* To measure the frequency of UGT genotypes in peripheral blood samples
* To evaluate the objective response rate using the RECIST criteria.
Study Oversight
Has Oversight DMC:
False
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?: