Validation of an Adjusted Dosing Algorithm of Carboplatin

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Treatments: Carboplatin

Criteria

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