Dose-banding of carboplatin: Effect on area under the plasma concentration - time curve (AUC) compared with individualised dosing - Carboplatin blood levels with dose-banded” and individualised systems

Phase 1

• Conditions: Conditions for which carboplatin is indicated for: 1. Advanced ovarian carcinoma of epithelial origin in: - first line therapy - second line therapy, after other treatments have failed. 2. Small cell carcinoma of the lung, in association with other chemotherapeutic agents.

• Registration Number: EUCTR2006-001094-15-GB
• Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust (Cancer Research UK Medical Oncology Unit, Churchill Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Patients aged over 18.
- Eligible to receive carboplatin as single agent or in combination therapy, according to institutional guidelines.
- At least two planned carboplatin cycles.
- Ability to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with ascites, oedema, or other expanded body space.
- Patients receiving intravenous (IV) hydration therapy.
- Pregnancy or breast feeding.
- Patients who do not understand the Patient Information sheet in English. (Considering the size and purpose of this study, it would not be economically feasible to provide separate information material in other languages for anyone who does not fully understand the Patient Information).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified