ISRCTN70833965
Completed
Phase 2
A phase II double-blind, randomised controlled trial of VEGF inhibitor axitinib monotherapy with early dynamic contrast-enhanced ultrasound monitoring in chemo-refractory third-line metastatic colorectal cancer
Imperial College of Science, Technology and Medicine (UK)0 sites51 target enrollmentOctober 25, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imperial College of Science, Technology and Medicine (UK)
- Enrollment
- 51
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must meet all of the following inclusion criteria to eligible for enrollment into the trial:
- •1\. 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.
- •2\. Failed at least two chemotherapy regimens in advanced disease.
- •3\. Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- •4\. Male and female, 18 years of age or older.
- •5\. ECOG performance status of 0 or 1\.
- •6\. Resolution of all acute toxic effects of prior therapy e.g. radiotherapy or surgical procedure to NCI CTCv4 grade \=1\.
- •7\. Adequate organ function as defined by the following criteria:
- •7\.1\. 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.
- •7\.2\. Total serum bilirubin \<1\.5 x ULN
Exclusion Criteria
- •Participants must be excluded if they present with any of the following exclusion criteria:
- •1\. Non\-exposed to both oxaliplatin and irinotecan FP based cytotoxic chemotherapy (prior pelvic radiation therapy including adjuvant or neoadjuvant chemoradiation therapy for resected rectal cancer is allowed provided it is completed within 4 weeks prior to study entry)
- •2\. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St John?s wort). Current use or anticipated need for treatment with drugs that are known CYP3A4 inhibitors (i.e., grapefruit juice, ketoconazole, nefazodone, itraconazole, miconazole, erythromycin, clarithromycin, telithromycin, verapamil, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine)
- •3\. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- •4\. Non\-English speaking
- •5\. Pregnancy, breastfeeding, or unwillingness/inability to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for up to 3 months after discontinuing study drug if of reproductive potential.
- •6\. Hypertension uncontrolled by medication (\>150/100 mmHg despite optimal medical therapy).
- •7\. Diagnosis of any second malignancy within the last 3 years that is potentially liable to interfere with study outcomes (basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma and hormone\-controlled locally advanced prostate cancer that has been adequately treated with no evidence of recurrent disease for 12 months, are allowed)
- •8\. Prior surgery or IMP within 4 weeks prior to study entry
- •9\. Current treatment within another therapeutic clinical trial.
Outcomes
Primary Outcomes
Not specified
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