Know Cancer

forgot password

Pharmacogenetics and Therapeutic Drug Monitoring for the Optimization of Fluoropyrimidine Treatment in Patients With Advanced Colorectal Cancer

Phase 4
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Pharmacogenetics and Therapeutic Drug Monitoring for the Optimization of Fluoropyrimidine Treatment in Patients With Advanced Colorectal Cancer

Inclusion Criteria:

- Cytological or histological proven diagnosis of colorectal cancer, metastatic or
inoperable advanced disease, not amenable to curative therapy

- Measurable disease, defined as at least one lesion (outside of irradiated areas) that
can be measured in at least one dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes)
according to RECIST v1.1

- Tumor either wild-type KRAS or KRAS-mutated

- Indication for the therapeutic use of continuous intravenous 5FU over 48 hours
("deGramont" regimen) or oral Cp, either alone or in combination with other
anticancer drugs (including monoclonal antibodies or other molecularly-targeted

- Eligible treatment regimens include: FOLFOX (FOLFOX 4, FOLFOX 6, modified FOLFOX 6,
FOLFOX 7), FOLFIRI, 5FU or Cp mono-chemotherapy ("deGramont" regimen), XELOX, XELIRI,
Capecitabine mono-chemotherapy

- All regimens may be combined with anti-VEGF or anti-EGFR targeted treatment such as
bevacizumab or cetuximab

- Patients receive first-line systemic treatment (previous adjuvant chemotherapy is
allowed, previous rectal radiochemotherapy is allowed if completed >/=1 months before
registration to the study)

- Written informed consent before registration to the trial

- The patient is willing to undergo pharmacogenetic and pharmacokinetic sampling and

- WHO performance status 0 or 1

- Female or male patients >18 years of age

- Adequate organ function (ANC, PLT, bilirubin 2xULN, creatinine clearance)

Exclusion Criteria:

- Known hypersensitivity to trial drug or any compounds of the drug

- Pregnant or breastfeeding women

- Patients with cerebral and/or leptomeningeal metastases are eligible, unless there is
a need for treatment with steroids

- Risk of rapid deterioration due to tumor symptoms or tumor complications

- Severe or uncontrolled cardiovascular disease (e.g. ACS, cardiac failure NYHA III or
IV, clinically relevant myopathy, history of myocardial infarction within the last 12
months, significant arrhythmias)

- Concurrent use of reversible or irreversible DPD-inhibitors, including brivudin,
sorivudin, eniluracil 5-chloro-2,4-dihydroxypyridine or with substances interfering
with the immunoassay, including theophylline and theobromine.

- Concurrent severe uncontrolled medical illness (judged by the investigator) which
could impair the ability of the patient to participate in the trial

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Predefined fluoropyrimidine-related (index) toxicity

Outcome Description:

Index toxicity is defined as follows: All adverse events CTC grades ≥3, including myelosuppression but excluding nausea and vomiting (that is often due to concurrent platinum drug treatment) Fluoropyrimidine-related toxicity CTC grade ≥2, including mucositis, dehydration, hand-foot syndrome Diarrhea CTC grade ≥2 lasting for >/=5 days or an increase of 2 CTC grades in case of preexisting diarrhea. Diarrhea should not be evaluated in patients with a colostomy

Outcome Time Frame:

After 6 weeks of fluoropyrimidine-based treatment

Safety Issue:


Principal Investigator

Markus Joerger, MD PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Cantonal Hospital St.Gallen (Switzerland)


Switzerland: Swissmedic

Study ID:

SG 343/12



Start Date:

October 2012

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • Genotyping
  • Area-under-the concentration-time curve
  • Toxicity
  • 5-fluorouracil
  • Capecitabine
  • Colorectal Neoplasms