NCT00611468

Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	Topotecan	All subjects receive treatment with intravenous topotecan and oral erlotinib.
DRUG	Erlotinib	All subjects receive treatment with intravenous topotecan and oral erlotinib.

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-02-11
• Last updated: 2011-08-22
• Results posted: 2011-07-19

Locations

1 site across 1 country: United States