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PAREO study


- candidate number27093
- NTR NumberNTR6356
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2017
- Secondary IDsMEC16-696 / NL59789.078.16 METC / ABR-nr
- Public TitlePAREO study
- Scientific TitlePAclitaxel Resistance Explained by pharmacokinetic parameters in patients with Oesophageal cancer
- ACRONYMPAREO
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria- Age 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- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-mrt-2017
- planned closingdate1-jan-2019
- Target number of participants14
- InterventionsPatients 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).
- Primary outcomea 25% reduction of the intra-tumoral concentrations of paclitaxel in cycle six compared to cycle one in oesophageal cancer patients.
- Secondary outcome1) 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.
- TimepointsDuring cycle 1 and 6 patients will get an upper endoscopy with biopsies and blood withdrawal for pharmacokinetics.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD F.M. de Man
- CONTACT for SCIENTIFIC QUERIESMD F.M. de Man
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD13-apr-2017 - 11-jun-2017


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