Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer

The purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of Axitinib.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut gustave roussy

Villejuif, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axitinib

Drug

Axitinib will be given BID orally. The 3 dose levels tested will be: 1st cycle: 5 mg BID; 2nd cycle: 7 mg BID; 3rd cycle: 10 mg BID.

One cycle is defined as a 14-day period (7 days ON / 7 days OFF). Patients will receive a first cycle of single agent axitinib at the starting dose with DCE-US assessment. If no study treatment-related adverse event (AE) of grade > 1 is observed during this cycle, intrapatient dose escalation will be performed for the second cycle. The same dose escalation method wil apply between the 2d and 3d cycles.

Primary outcomes

Echography measure

Time frame: baseline and on day 2, day 7, day 15, day 29, day 35 and day 43

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.

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: AXUS

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Dec 6, 2011
Registry last updated: Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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