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Metastatic Colorectal CancerPhase 2NCT00806663

FOLFIRI and Sunitinib in Metastatic Colorectal Cancer

A Phase 2 study testing sunitinib added to FOLFIRI in people with Metastatic Colorectal Cancer and Liver Metastases, run by Central European Society for Anticancer Drug Research at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
sunitinib added to FOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesGermany
Study dates
Aug 2008to Sep 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Innere Univ.-Klinik u. Poliklinik Tumorforschung

    Essen, D-45122

  • Klinik für Tumorbiologie

    Freiburg im Breisgau, D-79106

  • Medizinische Universitätsklinik der Albert-Ludwigs-Universität Freiburg

    Freiburg im Breisgau, D-79106

  • Marienhospital

    Herne, D-44625

Other trials in Germany

About this study

Official title: 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.

Being tested
sunitinib added to FOLFIRI
Keywords
mCRC, colorectal cancer, FOLFIRI, sunitinib, DCE-MRI, DCE-USI
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib added to FOLFIRIDrug

    Also called Sutent

    sunitinib 37 mg once daily (4 weeks on/2 weeks off)

Study groups in NCT00806663
Study groupRoleWhat they receive
Sunitinib ArmExperimentalSutent sunitinib 37 mg once daily (4 weeks on/2 weeks off)
Receives: Drug: sunitinib added to FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

Secondary outcomes (4)

  1. Antitumour response

    Measured: 9 months

  2. Time to progression (TTP)

    Measured: 9 months

  3. pharmacokinetics

    Measured: 12 weeks

  4. drug treatment safety

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2010
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806663
Sponsor's protocol ID
C-II-005 /2008-001515-37
Status last verified
Feb 2019
First submitted
10 Dec 2008
Last updated
6 Feb 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib added to FOLFIRI in people with Metastatic Colorectal Cancer and Liver Metastases, run by Central European Society for Anticancer Drug Research at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.

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