PHARMACOGENOMIC AND PHARMACOKINETIC SAFETY AND COST-SAVING ANALYSIS IN PATIENTS TREATED WITH FLUOROPYRIMIDINES
- Conditions
- cancer, treated with capecitabine or 5-FU in DPD-deficient individuals
- Registration Number
- EUCTR2007-000412-82-NL
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1.Histological or cytological proof of cancer
2.Patient is considered for treatment with capecitabine or 5-FU
3.Age 18 years
4.Able and willing to give written informed consent
5.Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis
6.Life expectancy ? 3 months allowing adequate follow up of toxicity evalution and antitumor activity
7.Minimal acceptable safety laboratory values
a.ANC of 1.5 x 109 /L
b.Platelet count of ? 100 x 109 /L
c.Hepatic function as defined by serum bilirubin ? 1.5 x ULN, ALT and AST ? 2.5 x ULN; in case of liver metastases ALT and AST = 5 ULN
d.Renal function as defined by serum creatinine ? 1.5 x ULN or creatinine clearance ? 50 ml/min (by Cockcroft-Gault formula).
8.WHO performance status of ? 2
9.No radio- or chemotherapy within the last 3 weeks prior to study entry
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
1.Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
2.Women who are pregnant or breast feeding
3.Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method