PAREO study

This is a single centre pharmacokinetic study in which patients will use weekly paclitaxel 100mg/m2 and carboplatin on AUC 4 as standard of care chemotherapy. Patients will get on two different days (first day of the first and sixth cycle) 5x 4ml blood withdrawal for pharmacokinetic analysis, biopsies of the oesophageal cancer (4-8x (6mm (mean) diameter) tissue samples) and normal appearing mucosa (4-8x (6mm (mean) diameter) tissue samples).To demonstrate a 25% reduction of the intra-tumoral concentrations of paclitaxel in cycle six compared to cycle one in oesophageal cancer patients. Secondary endpoints include the relationship of the intra-tumoral concentrations of paclitaxel with pharmacokinetic paclitaxel parameters in plasma (i.e. AUC, CL, Cmax and tmax) per cycle, paclitaxel concentrations in tumor tissue compared to normal appearing mucosa, the analysis and correlation of toxicity and tumor response to intra-tumoral paclitaxel concentrations.

A decline of intra-tumoral concentrations over time could be the first sign of the development of drug resistance by the tumor. In this exploratory study we will investigate the relationship between plasma and intra-tumoral paclitaxel concentrations over time.

During cycle 1 and 6 patients will get an upper endoscopy with biopsies and blood withdrawal for pharmacokinetics.

Patients will use weekly paclitaxel 100mg/m2 and carboplatin on AUC 4 as standard of care chemotherapy. Patients will get on two different days (first day of the first and sixth cycle) 5x 4ml blood withdrawal for pharmacokinetic analysis, biopsies of the oesophageal cancer (4-8x (6mm (mean) diameter) tissue samples) and normal appearing mucosa (4-8x (6mm (mean) diameter) tissue samples).