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The Optimisation of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer

Phase 2
21 Years
80 Years
Open (Enrolling)
Cancer (Advanced Stage)

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Trial Information

The Optimisation of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer

Inclusion Criteria:

- Patients aged = 21 years to 80 years

- Histologically proven advanced stage carcinoma where De Gramont, FOLFIRI or mFOLFOX-6
regimen is indicated.

- No more than one line of prior chemotherapy for advanced stage disease

- Measurable disease according to RECIST criteria or evaluable disease

- Karnofsky performance status of at least 70% or electrocorticogram performance
status ? 2

- A life expectancy of at least 3 months

- absolute neutrophil count > 1.5 x 10^9/L

- Platelet count > 100 x 10^9/L.

- Total bilirubin > 1.5x upper limits of normal reference range (ULN)

- AST/ALT levels > 2.5x upper limit of normal. If hepatic metastases are present, these
parameters could be ? 5x the ULN.

- Women of reproductive age and men must agree to practice effective contraception
during the entire study period. Postmenopausal women must have been amenorrheic for
at least 12 months to be considered of non-child-bearing potential. Females with
childbearing potential must have a negative serum pregnancy test within 7 days prior
to study enrollment. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

- Signed informed consent

Exclusion Criteria:

- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy,
hormonal, biologic or any investigational therapy within 21 days prior to study drug
administration (6 weeks for mitomycin or nitroureas) and have not recovered from

- Patients who have not recovered from major surgery

- Subjects with treated brain metastases are eligible provided they are asymptomatic
and do not require corticosteroids (must have discontinued steroids at least 1 week
prior to study drug administration).

- Clinically significant cardiac disease, e.g. myocardial infarction within the last 12

- Known HIV infection

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, other serious uncontrolled concomitant disease, psychiatric illness/
social situation that would limit study compliance.

- Known allergies to any component of the drug regime

- Organ allografts

- Known dihydropyrimidine dehydrogenase deficiency

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

AUC of 20-24 mg.h/L

Outcome Description:

If patient achieved target AUC for two consecutive cycles, therapeutic dose monitoring will performed every alternate cycle.

Outcome Time Frame:

28 days - 2 cycles

Safety Issue:


Principal Investigator

Thomas Soh, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

June 2009

Completion Date:

June 2015

Related Keywords:

  • Cancer (Advanced Stage)