A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes. - C-5FU-TDM

• Conditions: Metastatic colorectal cancer; MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003553-26-DE
• Lead Sponsor: CESAR Central European Society for Anticancer Drug Research-EWIV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-03
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1)Capable of understanding the protocol requirements and risks, and providing written informed consent.
(2)Patients with histologically confirmed metastatic colorectal cancer.
(3)ECOG Performance Status (ECOG-PS) status = 2.
(4)Female or male patients of 18 years of age or older
(5)Life expectancy > 3 months
(6)Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier method of contraception), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active male patients must also use acceptable contraceptive methods (condom).
(7)An absolute neutrophil count >1.5/nl
(8)Platelet count > 100/nl.
(9)Total bilirubin = 2 x upper limit of normal.
(10) AST and ALT = 2.5 x upper limit of normal, or = 5 x upper limit of normal in case of liver metastases.
(11)Serum creatinine = 2x upper limit of normal
(12)Hemoglobin = 9 g/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

(1)Symptomatic brain metastasis.
(2)Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study.
(3)Unwilling or unable to follow protocol requirements or to give informed consent.
(4)Any treatment with cytotoxic or biologic agents within the 4weeks prior to beginning treatment on this study. At least 4 weeks must have elapsed from any prior surgery or radiation.
(5)Unresolved toxicity from prior chemotherapy (including approved and experimental drugs) greater than grade I.
(6) Known Dihydropyrimidine dehydrogenase (DPD) deficiency

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.;Secondary Objective: To determine whether pharmacokinetically-guided dose adjustment of 5-FU is able to reduce treatment-related toxicities.;Primary end point(s): To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. ;Timepoint(s) of evaluation of this end point: The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To determine whether pharmacokinetically-guided dose adjustment of 5-FU is able to reduce treatment-related toxicities.;Timepoint(s) of evaluation of this end point: Treatment related toxicities will be assesst throughout the study.