A study to see how effective the drug Axitinib is at preventing cancer cells from growing and to see if this means that patients with kidney cancer require less extensive surgery
- Conditions
- Clear cell renal cell cancer with venous thrombus invasionCancer
- Registration Number
- ISRCTN96273644
- Lead Sponsor
- Common Services Agency
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35739300/ (added 29/07/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Current inclusion criteria as of 11/02/2019:
1. Aged 18 years and over
2. Biopsy-proven clear cell RCC
3. Immediate resection of the primary tumour considered technically possible
4. The patient must be suitable for and willing to undergo nephrectomy surgery
5. The clinical (radiologically determined) stage of the tumour must be into the main renal vein (cT3a, but seen in the main branch of the renal vein leading to but not beyond the vein ostium with the inferior vena cava (IVC)), or the IVC itself either below of above the diaphragm (cT3b or cT3c respectively)
6. Nodal status may be clinically node negative (cN0) on CT, indeterminate (cNx) or clinically node positive on CT (cN1)
7. Non-metastatic (M0) and metastatic (M1) clear cell renal cell patients
8. The patient must have an ECOG performance status of either 0 or 1
9. Urine must contain less than 2 g protein. If urine contains =2 g then a 24-h urine collection or urinary protein creatinine ratio (PCR) should be performed and the patient may enter NAXIVA only if urinary protein is <2g per 24 hours or PCR <200mg/mmol.
10. Serum Creatinine =1.5xULN or estimated Creatinine clearance =30mL/min as calculated using the Cockcroft- Gault (CG) equation.
11. All female patients with reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment.
Previous inclusion criteria as of 23/04/2018:
1. Aged 18 years and over
2. Biopsy-proven clear cell RCC
3. Immediate resection of the primary tumour considered technically possible
4. The patient must be suitable for and willing to undergo nephrectomy surgery
5. The clinical (radiologically determined) stage of the tumour must be into the main renal vein (cT3a, but seen in the main branch of the renal vein leading to but not beyond the vein ostium with the inferior vena cava (IVC)), or the IVC itself either below of above the diaphragm (cT3b or cT3c respectively)
6. Nodal status may be clinically node negative (cN0) on CT, indeterminate (cNx) or clinically node positive on CT (cN1)
7. Non-metastatic (M0) and metastatic (M1) clear cell renal cell patients
8. The patient must have an ECOG performance status of either 0 or 1
9. Urine must contain less than 2 g protein. If urine contains =2 g then a 24-h urine collection should be performed and the patient may enter if urinary protein is <2 g per 24 hours.
10. All female patients with reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment.
Previous inclusion criteria:
1. Aged 18 years and over
2. Biopsy proven clear cell RCC
3. Resectable Tumour
4. The clinical (radiologically determined) stage of the tumour must be into the main renal vein (cT3a, but seen in the main branch of the renal vein leading to but not beyond the vein ostium with the inferior vena cava (IVC)), or the IVC itself either below of above the diaphragm (cT3b or cT3c respectively)
5. Nodal status may be clinically node negativ
Current exclusion criteria as of 11/02/2019:
1. Metastatic patients with poor risk on the Memorial Sloan Kettering Cancer Centre (MSKCC) score and deemed suitable for cytoreductive nephrectomy at time of enrolment
2. Other invasive malignancy within the last 2 years. Patients with previous history of malignancies with a negligible risk of metastasis or death and treated with expected curative intent are eligible, for example but not exclusively:
2.1. Carcinoma in situ of the cervix.
2.2 Basal or squamous cell skin cancer.
2.3 Localized low to intermediate risk prostate cancer treated with curative intent and absence of prostate specific antigen (PSA) relapse; or prostate cancer (Stage T1/T2a, Gleason =6 and PSA
3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.
4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, pulmonary disease other than directly related to RCC
5. Gastrointestinal abnormalities including:
5.1. Inability to take oral medication
5.2. Requirement for intravenous alimentation
5.3. Prior surgical procedures affecting absorption including total gastric resection
5.4. Treatment for active peptic ulcer disease in the past 6 months
5.5. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy
5.6. Malabsorption syndromes
6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 8.12, concomitant therapy)
7. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy)
8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
9. Active seizure disorder, spinal cord compression, or carcinomatous meningitis
10. Any of the following within 12 months prior to study entry:
10.1 myocardial infarction
10.2 uncontrolled angina
10.3 coronary/peripheral artery bypass graft
10.4 symptomatic congestive heart failure
10.5 cerebrovascular accident or transient ischemic attack
11. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment)
12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
13. ALT or AST =1.5 x upper limit of normal; Bilirubin =1.5 x upper limit of normal
14. Serum creatinine =1.5 x upper limit of normal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thrombus invasion will be measured using MRI scanning according to the Mayo classification at baseline and pre-surgery (week 9).
- Secondary Outcome Measures
Name Time Method