FOLFIRI and Sunitinib in Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806663
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : September 10, 2012
Information provided by (Responsible Party):
Central European Society for Anticancer Drug Research

December 10, 2008
December 11, 2008
September 10, 2012
August 2008
July 2010   (Final data collection date for primary outcome measure)
reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases. [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00806663 on Archive Site
  • Antitumour response [ Time Frame: 9 months ]
  • Time to progression (TTP) [ Time Frame: 9 months ]
  • pharmacokinetics [ Time Frame: 12 weeks ]
  • drug treatment safety [ Time Frame: 9 months ]
Same as current
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FOLFIRI and Sunitinib in Metastatic Colorectal Cancer
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

This is an open label single arm prospective multicenter Phase II study in around 20 patients. The primary objective of this study is to evaluate whether the addition of sunitinib to FOLFIRI results in a significant reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.

Secondary objectives are antitumor response, time to progression (TTP), effect on pharmacokinetics of sunitinib and biomarkers (VEGF und soluble VEGF-receptor) and drug/treatment safety.

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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metastatic Colorectal Cancer
  • Liver Metastases
Drug: sunitinib added to FOLFIRI
sunitinib 37 mg once daily (4 weeks on/2 weeks off)
Other Name: Sutent
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2011
July 2010   (Final data collection date for primary outcome measure)

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 marrow.
  • 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
C-II-005 /2008-001515-37
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Central European Society for Anticancer Drug Research
Central European Society for Anticancer Drug Research
Not Provided
Study Chair: Klaus Mross, MD Klinik für Tumorbiologie
Central European Society for Anticancer Drug Research
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP