ISRCTN08193901CompletedPhase 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 enrollmentStarted: April 23, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •8.3. Haemoglobin greater than or equal to 8 g/dl (may be transfused to maintain or exceed this level)
- •9. Adequate liver function:
- •9.1. Total bilirubin less than 1.5 x upper limit of normal (ULN), and
- •9.2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 x ULN in patients without liver metastases; less than 5 x ULN in patients with liver metastases
- •10. Adequate renal function:
- •10.1. Serum creatinine less than or equal to 1.5 x ULN, and
- •10.2. Urine dipstick for proteinuria less than 2+. Patients discovered to have greater than or equal to 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate less than 1 g of protein in 24 hours
- •11. International normalised ratio (INR) less than or equal to 1.5 within 7 days prior to enrolment. Anticoagulation is allowed if target INR is less than 3 and INR is therapeutic on a stable dose of coumarin-type anticoagulation, or if subject is on a stable dose of low molecular weight (LMW) heparin for greater than 2 weeks at time of enrolment
- •12. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of the study and for 9 months afterwards. Women who wish to breastfeed are not eligible for the study
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
- •11. Serious, non-healing wound, ulcer, or bone fracture
- •12. Pregnant or breast-feeding mothers
- •13. No contraindication to MRI scanning e.g. no history of claustrophobia, metal fragment implantation
- •14. Current active second malignancy other than non-melanoma skin cancers and post-treatment for localised prostate cancer. Patients are not considered to have a currently active malignancy if they are in complete remission for greater than 3 years prior to study
- •15. Patients with a history of allergic reactions to contrast agents
- •16. Patients with gross ascites
- •17. Seizure disorder requiring medication
- •18. Human immunodeficiency virus (HIV)/hepatitis B/hepatitis C/other infection greater than common toxicity criteria grade 2 (CTC 2); active clinically serious bacterial or fungal infections (greater than CTC 2)
- •19. Other investigational drug during trial or within 30 days
- •20. Any other significant medical illness or medically significant abnormal laboratory finding that would, in the investigator's judgment, make the patient inappropriate for this study, or would increase the risk associated with the patients' participation in the study
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