ISRCTN08193901
Completed
Phase 2
Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) assessment of the vascular changes induced with bevacizumab alone and in combination with interferon-alpha in patients with advanced renal cell carcinoma: a phase II, open labelled, randomised, multicentre trial
East and North Hertfordshire NHS Trust (UK)0 sites30 target enrollmentApril 23, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced or metastatic renal cell carcinoma
- Sponsor
- East and North Hertfordshire NHS Trust (UK)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects greater than or equal to 18 years
- •2\. Patients with previously untreated metastatic (stage IV) or locally advanced (inoperable stage III) renal cell carcinoma (RCC)
- •3\. Subject with histologically and/or cytologically confirmed advanced RCC, of which a majority component of conventional clear\-cell type is mandatory. Tumours of mixed histology should be categorised by the predominant cell type.
- •4\. Good or intermediate prognosis disease as defined by Motzer score
- •5\. Response Evaluation Criteria In Solid Tumors (RECIST) measurable lesion(s), which must be amenable to DCE\-MRI scanning
- •6\. Life expectancy of at least 12 weeks
- •7\. Eastern Co\-operative Oncology Group (ECOG) performance status 0 \- 2
- •8\. Adequate haematological function:
- •8\.1\. Absolute neutrophil count (ANC) greater than or equal to 1\.5 x 10^9/l, and
- •8\.2\. Platelet count greater than or equal to 100 x 10^9/l, and
Exclusion Criteria
- •1\. Diagnosis of brain metastasis
- •2\. Major surgery (including open biopsy) or radiation therapy within 28 days prior to enrolment (palliative radiotherapy to painful bone lesions is allowed within 14 days prior to enrolment). Subjects must have recovered from prior surgery (greater than 28 days) and radiation (greater than 28 days \- 14 days if palliative radiotherapy to painful bone lesions)
- •3\. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrolment
- •4\. Significant cardiovascular disease defined as congestive heart failure (New York Heart Association \[NYHA] class II, II or IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment
- •5\. Inadequately controlled hypertension (defined as a blood pressure of greater than 150 mmHg systolic and/or greater than 100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
- •6\. History of stroke or transient ischaemic attack within 6 months prior to enrolment
- •7\. Significant vascular disease (e.g., aortic aneurysm, aortic dissection), or symptomatic peripheral vascular disease
- •8\. Evidence or history of recurrent thromboembolism (more than one episode of deep vein thrombosis \[DVT]/pulmonary embolism \[PE]) during the past 6 months, bleeding diathesis or coagulopathy
- •9\. Chronic daily intake of aspirin greater than 325 mg/day or clopidogrel greater than 75 mg/day, or steroids (prednisone greater than 12\.5 mg/day or dexamethasone greater than 2 mg/day), excluding inhaled steroids
- •10\. History of abdominal or tracheo\-oesophagel fistula, gastrointestinal perforation, or intra\-abdominal abscess within 6 months prior to study enrolment
Outcomes
Primary Outcomes
Not specified
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