FOLFIRI and Sunitinib in Metastatic Colorectal Cancer

NCT00806663 | Completed Phase 2

• 1 other identifier: C-II-005 /2008-001515-37
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief 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, 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.

Conditions

Metastatic Colorectal Cancer; Liver Metastases

Keywords

mCRC; colorectal cancer; FOLFIRI; sunitinib; DCE-MRI; DCE-USI

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (4)

• Antitumour response

  9 months

• Time to progression (TTP)

  9 months

• pharmacokinetics

  12 weeks

• drug treatment safety

  9 months

Study Arms (1)

Sunitinib Arm

EXPERIMENTAL

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

Drug: sunitinib added to FOLFIRI

Interventions

sunitinib added to FOLFIRI DRUG

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

Also known as: Sutent

Sunitinib Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Central European Society for Anticancer Drug Research: lead

Study Sites (4)

Innere Univ.-Klinik u. Poliklinik Tumorforschung

Essen, D-45122, Germany

Location

Klinik für Tumorbiologie

Freiburg im Breisgau, D-79106, Germany

Location

Medizinische Universitätsklinik der Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Marienhospital

Herne, D-44625, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Klaus Mross, MD

  Klinik für Tumorbiologie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2011
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

DE (4)