Paclitaxel resistance explained by pharmacokinetic parameters in patients with oesophageal cancer

Paclitaxel resistance explained by pharmacokinetic parameters in patients with oesophageal cancer - PAREO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45324

Enrollment

Registered

2017-02-28

Start date

2017-10-23

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the oesophagus Oesophaguscarcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary objective is to demonstrate a 25% reduction of the intra-tumoral concentrations of paclitaxel in cycle five 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 to intra-tumoral paclitaxel concentrations. 4) To correlate tumor response with intra-tumoral paclitaxel concentrations	—

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 to intra-tumoral paclitaxel concentrations. 4) To correlate tumor response with intra-tumoral paclitaxel concentrations

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Countries

Netherlands

Outcome results