Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractor… (NCT04355156) | Clinical Trial Compass
CompletedPhase 2
Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer
United Kingdom52 participantsStarted 2012-09-17
Plain-language summary
This is a study of Axitinib versus placebo as monotherapy for people with colorectal cancer who have liver metastases and who have relapsed within 6 months of their last chemotherapy regime. The research will also look at the potential of CEHPI (Contrast Enhanced Hepatic Perfusion Index) reduction, a technique developed for this research to measure the changes in how the blood vessels pump blood into the different liver metastases (tumours) and therefore to assess and predict response to treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with liver metastas(es). At least one of which should not have had any focal therapy including radiofrequency ablation, chemoembolization, ethanol or cryoablation.
* Failed at least 2 chemotherapy regimens in advanced disease.
* Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
* 18 years of age or older.
* ECOG performance status of 0 or 1.
* Resolution of all acute toxic effects of prior therapy e.g. radiotherapy or surgical procedure to NCI CTCv4 grade ≤1.
* Adequate organ function as defined by the following criteria:
Serum aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine aminotransferase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤2.5 x upper limit of normal (ULN). For patients with liver metastases, \<5 x ULN.
Total serum bilirubin \<1.5 x ULN Serum albumin ≥3.0 g/dL Absolute neutrophil count ≥1500/µL Platelets ≥100,000/µL Haemoglobin ≥9.0 g/dL Serum creatinine ≤1.5 x ULN
* Signed and dated informed consent form
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient reported outcome measures.
* At least 2 weeks since the end of prio…
What they're measuring
1
Overall Survival
Timeframe: Through study completion, an average of 1 year