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

Gustave Roussy

Status: Completed

Conditions: Colorectal Carcinoma

Treatments: Drug: axitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01486251

2011/1738 (Other Identifier)

2011-001151-37

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

27 participants in 1 patient group

experimental

Experimental group

Description:

axitinib will be given BID orally. One cycle is defined as a 14-day period (7 days ON / 7 days OFF). The 3 dose levels tested will be: 1st cycle: 5 mg BID; 2nd cycle: 7 mg BID; 3rd cycle: 10 mg BID. 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.

Treatment:

Drug: axitinib