Oesophagus carcinoma, cancer, paclitaxel, intra-tumoral
Conditions
Interventions
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 wi
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Age ¡Ý 18 years - Oesophagus carcinoma - WHO Performance Status 0-1 - Treatment with weekly paclitaxel 100mg/m2 and carboplatin on AUC 4 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
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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a 25% reduction of the intra-tumoral concentrations of paclitaxel in cycle six compared to cycle one in oesophageal cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To correlate the intra-tumoral concentrations of paclitaxel with pharmacokinetic paclitaxel parameters in plasma (i.e. AUC, CL, Cmax and tmax) per cycle. 2) To compare the concentrations of paclitaxel in tumor tissue compared to normal appearing mucosa. 3) To evaluate and to correlate toxicity with intra-tumoral paclitaxel concentrations. 4) To correlate tumor response (by RECIST) with intra-tumoral paclitaxel concentrations. | — |
Contacts
Public ContactF.M. de Man
Erasmus MC Cancer Institute - Department of Internal Oncology
Outcome results
None listed