Conditions: Metastatic Solid Tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

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.

Arms:
arm 1: All subjects receive treatment with intravenous topotecan and oral erlotinib.

Interventions: intervention 1: Topotecan intervention 2: Erlotinib
Intervention descriptions: intervention 1: All subjects receive treatment with intravenous topotecan and oral erlotinib. intervention 2: All subjects receive treatment with intravenous topotecan and oral erlotinib.

Protocol document: