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A Prospective Angiogenic Imaging Study With DCE-MRI and DCE-USI in Patients With Colorectal Cancer and Liver Metastases Receiving Sunitinib in Addition to 5-FU, Folinic Acid and Irinotecan (FOLFIRI) as 1st Line Therapy

Phase 2
18 Years
80 Years
Not Enrolling
Metastatic Colorectal Cancer, Liver Metastases

Thank you

Trial Information

A Prospective Angiogenic Imaging Study With DCE-MRI and DCE-USI in Patients With Colorectal Cancer and Liver Metastases Receiving Sunitinib in Addition to 5-FU, Folinic Acid and Irinotecan (FOLFIRI) as 1st Line Therapy

Inclusion Criteria:

- Adult males and females: over 18 years of age.

- Patients with histologically or cytologically confirmed colorectal cancer who will
receive their first palliative treatment.

- Patients who have at least one measurable hepatic lesion of 2 cm or more according to
RECIST criteria.

- ECOG 0 or 1.

- Signed written informed consent.

- White blood cell count (WBC)>= 4x10^9/L with neutrophils >= 1.5 x 10*9/L, platelet
count >= 100x10*9/L, hemoglobin >= 5.6 mmol/L (10 g/dL).

- Total bilirubin =< 2 x upper limit of normal.

- AST and ALT =< 2.5 x upper limit of normal, or =< 5 x upper limit of normal in case
of liver metastases.

- Serum creatinine =< 1.5 x upper limit of normal or creatinine clearance > 60 ml/min

- Normal ECG without QT prolongation.

Exclusion Criteria:

- Resectable liver metastasis.

- Adjuvant therapy with FOLFOX or 5-FU / Capecitabine =< 6 months prior to treatment on
study or any previous palliative chemotherapy..

- Any contraindication for FOLFIRI chemotherapy regimen.

- Any investigational drug within the 30 days before inclusion.

- Prior use of sunitinib or other multitarget tyrosine kinase inhibitors or VEGF
pathway directed treatments like bevacizumab.

- Known or suspected allergy or hypersensitivity reaction to any of the components of
study treatments.

- Pregnancy (absence to be confirmed by beta-hCG test) or lactation period

- Men or women of child-bearing potential who are sexually active and unwilling to use
a medically acceptable method of contraception during the trial

- Clinically symptomatic brain or meningeal metastasis. (known or suspected)

- Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin).

- History of any of the following cardiac events within the past 6 months:

- myocardial infarction (including severe/ unstable angina),

- coronary/peripheral artery bypass graft,

- congestive heart failure (CHF),

- cerebrovascular accident,

- transient ischemic attack pulmonary embolism.

- History of clinically significant bleeding within the past 6 months, including gross
hemoptysis or haematuria, or underlying coagulopathy.

- History of peptic ulcer disease, deep vein thrombosis, or other significant
thrombo-embolic event within the past 6 months.

- Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below
90 mm Hg despite the use of >= 3 anti-hypertensive drugs.

- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or
chronic diarrhea.

- Previous malignancy (other than colorectal cancer) in the last 5 years except basal
cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder
tumor [Ta, Tis and T1].

- History of organ allograft

- Treatment with potent CYP3A4 inhibitor within 7 days of sunitinib/placebo dosing or
with potent CYP3A4 inducer within 12 days of sunitinib/placebo dosing.

- Prior full field radiotherapy =< 4 weeks, or limited field radiotherapy, =< to 2
weeks prior to study enrollment; or previous radiation treatment >30% of the bone

- Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks
before starting treatment; anticipation of need for major surgical procedure (e.g.
impending bowel obstruction) during the course of the study.

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment, unless affected area has been
removed surgically.

- Significant disease which, in the investigator's opinion would exclude the patient
from the study.

- Patients with seizure and epileptic disorder or other conditions requiring medication
such as phenytoin, carbamazepin, phenobarbital.

- Patients requiring long-term cortisone therapy.

- Patients requiring oral anticoagulation treatment (marcoumar).

- Known alcohol or drug abuse.

- Medical or psychological conditions that would not permit the patient to complete the
study or sign informed consent.

Type of Study:


Study Design:

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

Outcome Measure:

reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Klaus Mross, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinik für Tumorbiologie


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

C-II-005 /2008-001515-37



Start Date:

August 2008

Completion Date:

September 2011

Related Keywords:

  • Metastatic Colorectal Cancer
  • Liver Metastases
  • mCRC
  • colorectal cancer
  • sunitinib
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms