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

NCT01486251 | Completed

• 2 other identifiers: 2011-001151-372011/1738
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Echography measure

  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.

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

Study Arms (1)

experimental

EXPERIMENTAL

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.

Drug: axitinib

Interventions

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.

experimental

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut gustave roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Axitinib

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)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michel Ducreux

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: December 6, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

FR (1)