CYP3A4 phenotype-based dosing of irinoteca

Completed

Conditions: Cancer
Malignant neoplasm without specification of site

Registration Number: ISRCTN84131514

Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Histological or cytological confirmed diagnosis of any form of cancer, which is thought to be sensitive to irinotecan-treatment
2. Aged 18 years or older, either sex
3. World Health Organization (WHO) performance status 0 or 1
4. Adequate haematological functions, as determined 2 weeks before inclusion and within 2 days before start of irinotecan infusion (neutrophil count greater than 2.0 x 10^9/l, platelets greater than 100 x 10^9/L)
5. Adequate renal and hepatic functions, as determined 2 weeks before inclusion and within 2 days before start of irinotecan infusion (bilirubin less than 1.25 x upper limit of normal [ULN]; serum glutamic oxaloacetic transaminase [SGOT]/serum glutamic pyruvate transaminase [SGPT] less than 2.5 x ULN, in case of liver metastasis less than 5 x ULN; serum creatinine less than 1.25 x ULN; alkaline phosphatase [AP] less than 5 x ULN; gammaGT less than 200 U/l)
6. Written informed consent
7. Complete workup within 2 weeks prior to chemotherapy

Exclusion Criteria

1. Pregnant or lactating patients
2. Other serious illness or medical unstable conditions requiring treatment
3. Symptomatic central nervous system (CNS) metastases
4. History of psychiatric disorder
5. Time between last anti-tumour chemotherapy treatment and first day of irinotecan therapy less than 4 weeks
6. Radiotherapy within 4 weeks before chemotherapy, unless less than 20% of bone marrow area is involved
7. (Recent) radiotherapy at abdomen
8. Major surgery within 4 weeks before study entry
9. Unresolved bowel obstruction or chronic colic disease
10. Use of, and unwillingness to abstain from grapefruit (juice), herbal supplements/tea/over the counter medicines during the study period (starting 3 weeks before the first course). (Chronic) use of CYP3A and Pgp inhibiting/inducing medication, dietary supplements, or other inhibiting compounds.