Study to determine the precision and safety of the anticancer drug carboplatin after dosing according to a new dosing algoritm

Active, not recruiting

• Conditions: non-small cell lung cancer, small cell lung cancer, ovarian cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000234-33-NL
• Lead Sponsor: rijnstate hospital, the netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-14
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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
ohaemoglobin = 6.0 mmol/L
owhite blood cell count = 3.0 * 109/L
oabsolute neutrophil count (ANC) = 1.5 * 109/L
oplatelets = 100/L
obilirubin = 1.5 times ULN
oALAT and ASAT = 2.5 times ULN (in case of liver metastases = 5.0 times ULN).
-estimated life expectancy of at least 12 weeks

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Female patients should not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs.

-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

Study & Design

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