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Assessment of the Tumor Vascular Effects of the Pan-vegfr Tyrosine Kinase Inhibitor Axitinib Using Dynamic Contrast-enhanced Ultrasonography (Dce-us) in Patients With Refractory Metastatic Colorectal Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Carcinoma

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Trial Information

Assessment of the Tumor Vascular Effects of the Pan-vegfr Tyrosine Kinase Inhibitor Axitinib Using Dynamic Contrast-enhanced Ultrasonography (Dce-us) in Patients With Refractory Metastatic Colorectal Cancer


Inclusion Criteria:



- Patients with histologically confirmed diagnosis of CRC

- Measurable metastatic disease to the liver in proven disease progression (according
to RECIST criteria) at baseline (within 4 weeks prior to study entry), with at least
one lesion > 2cm considered appropriate for DCE-US examination

- Previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3
administered at optimal doses, over one or two chemotherapy (CT) lines for metastatic
disease with a clear resistance to these drugs. Previous exposure to bevacizumab
and/or anti-EGFR monoclonal antibody is allowed.

- Age ≥18 years; Performance Status (PS) 0-2 and life expectancy > 3 months.

- Adequate biological functions: Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L;
Hemoglobin > 9 g/dl; Creatinine clearance > 30 ml/min (cockcroft & Gault formula).
Serum bilirubin < 1,5 x the upper normal limit (UNL) and AST/ALT < 5 x UNL.

- Signed written informed consent

- Female patients with childbearing potential (<2 years after last menstruation) and
male must use effective means of contraception during the study treatment and at
least 6 months after the last study drug administration.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Echography measure

Outcome Description:

Variation of the total area under the curve (tAUC) measured by DCE-US in the region of interest (ROI) between baseline and the end of each axitinib cycle at increasing dose.

Outcome Time Frame:

baseline and on day 2, day 7, day 15, day 29, day 35 and day 43

Safety Issue:

No

Principal Investigator

Michel Ducreux

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSET2011/1738

NCT ID:

NCT01486251

Start Date:

September 2011

Completion Date:

June 2014

Related Keywords:

  • Colorectal Carcinoma
  • Carcinoma
  • Colorectal Neoplasms

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