Paclitaxel resistance explained by pharmacokinetic parameters in patients with oesophageal cancer

Completed

Conditions: cancer of the oesophagus
Oesophaguscarcinoma
10017991

Registration Number: NL-OMON45324

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

* Age * 18 years
* Oesophagus carcinoma
* WHO Performance Status 0-1
* Treatment with weekly paclitaxel and carboplatin is indicated
* Written informed consent
* Patients with safely accessible tumor by upper endoscopy
* No concurrent medication or supplements which can interact with paclitaxel during the study period

Exclusion Criteria

* Pregnant or lactating patients
* Previously treatment with radiotherapy on the oesophagus
* Patients who are unable to undergo upper endoscopy
* Patients with a stenosing oesophagus carcinoma prohibiting upper endoscopy
* Contra-indication for the use of midazolam and/or fentanyl (e.g. neuromuscular diseases, severe cardiac/pulmonary disease)
* Bilirubin > 1.5 x ULN, ASAT > 5x ULN, ALAT >5x ULN
* Serum creatinin > 2 x ULN and/or creatinin clearance < 45 mL/min (calculated with Cockroft-Gault formula)
* Patients with evidence or history of any bleeding diathesis, irrespective of severity
* Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
* Serious illness or medical unstable condition prohibiting adequate treatment and follow-up.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective is to demonstrate a 25% reduction of the intra-tumoral<br /><br>concentrations of paclitaxel in cycle five compared to cycle one in oesophageal<br /><br>cancer patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To correlate the intra-tumoral concentrations of paclitaxel with<br /><br>pharmacokinetic paclitaxel parameters in plasma (i.e. AUC, CL, Cmax and tmax)<br /><br>per cycle. 2) To compare the concentrations of paclitaxel in tumor tissue<br /><br>compared to normal appearing mucosa. 3) To evaluate and to correlate toxicity<br /><br>to intra-tumoral paclitaxel concentrations. 4) To correlate tumor response with<br /><br>intra-tumoral paclitaxel concentrations</p><br>