---
title: Validation of an Adjusted Dosing Algorithm of Carboplatin
nct_id: NCT02103244
overall_status: UNKNOWN
phase: PHASE4
sponsor: Rijnstate Hospital
study_type: INTERVENTIONAL
primary_condition: Cancer
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02103244.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02103244"
ct_last_update_post_date: 2014-04-03
last_seen_at: "2026-05-12T06:35:15.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Validation of an Adjusted Dosing Algorithm of Carboplatin

**Official Title:** Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function

**NCT ID:** [NCT02103244](https://clinicaltrials.gov/study/NCT02103244)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Rijnstate Hospital
- **Conditions:** Cancer
- **Start Date:** 2014-09
- **Completion Date:** 2015-12
- **CT.gov Last Update:** 2014-04-03

## Brief Summary

An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care.

## Detailed Description

Carboplatin is an alkylating anticancer drug that is used for the treatment of various types of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), malignant mesothelioma, ovarian cancer, and breast cancer. It is mostly given in combination with other chemotherapeutic drugs, but it can also be given as single agent.

Since carboplatin is highly eliminated by the kidneys, the dose needs to be adjusted for renal dysfunction. Furthermore, as there is clear correlation between the area under the concentration-time curve (AUC) of carboplatin and haematological toxicity and response rate, carboplatin is dosed per target AUC. For this, the standard pharmacokinetic formula \[dose = clearance carboplatin x target AUC\] is used.

the clearance is typically calculated using the cockcroft and gault (C-G) formula. In patients with high weight, or very low serum creatinine values the C-G-formula may overestimate the renal function, resulting in a potential overdose of carboplatin. the new developed dosing algorithm to be studied adjusts for high BMI and low serum creatinine values, in order to provide a more safe dose of carboplatin

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* histologically or cytologically proven advanced NSCLC, SCLC or ovarian cancer
* to be treated with carboplatin with a target AUC of 4, 5 or 6
* age 18 years or older
* WHO performance status 0 - 2
* adequate bone marrow and liver function defined as

  * haemoglobin ≥ 6.0 mmol/L
  * white blood cell count ≥ 3.0 \* 109/L
  * absolute neutrophil count (ANC) ≥ 1.5 \* 109/L
  * platelets ≥ 100/L
  * bilirubin ≤ 1.5 times ULN
  * ALAT and ASAT ≤ 2.5 times ULN (in case of liver metastases ≤ 5.0 times ULN).
* estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Treatment with carboplatin with a target AUC of \<4
* active clinically serious infection
* history of a kidney allograft
* pregnant
* patients not suitable for follow-up
* pregnancy or breast-feeding
```

## Arms

- **carboplatin** (EXPERIMENTAL) — An adjusted dosing algorithm will be applied to calculate the dose of carboplatin. in 24 patients blood will be obtained in order to determine the pharmacokinetics of carboplatin after adjusted dosing

## Interventions

- **Carboplatin** (DRUG) — carboplatin will be dosed according to newly developed dosing algorithm.

## Primary Outcomes

- **to the determine the mean absolute precision error and the mean prediction error of the AUC of carboplatin after dosing carboplatin according to the new dosing algorithm** _(time frame: 1 year)_

## Secondary Outcomes

- **Assessment of the incidence and severity of all adverse events that occurred during treatment with carboplatin** _(time frame: 1 year)_

## Locations (1)

- Rijnstate Hospital, Arnhem, Netherlands

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rijnstate hospital|arnhem||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02103244.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02103244*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*