ABOUT THIS STUDY
1. Age ≥ 18. 2. Histologically proven clear cell RCC. 3. Immediate resection of the primary tumour considered technically possible. 4. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) 4. cT3b, cT3c, cT3a (main renal vein) 5. N0, N1, or Nx 6. M0, or M1 7. ECOG performance status 0 - 1 8. Urinalysis <2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed and the patient may enter NAXIVA only if urinary protein is <2g per 24 hours.
9. 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.
1. For M1 patients: poor risk on Memorial Sloan Kettering Cancer Centre (MSKCC) score and
deemed suitable for cytoreductive nephrectomy at time of enrolment.
2. The presence of active second malignancy. Patients will be eligible if they have
adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical
cancer, stable prostate cancer or if treated with curative intent for any other cancer
with no evidence of disease for 2 years. Patients with prostate cancer will be
permitted entry if not receiving treatment and prostrate-specific antigen (PSA) is not
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 and up to 1 week after treatment.
Male patients must be surgically sterile or must agree to use effective contraception
during the period of therapy and for 6 months after completion of study drug (Patients
who do not meet this will not be are not eligible).
4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine or
pulmonary disease other than directly related to RCC.
5. Gastrointestinal abnormalities including: a. inability to take oral medication; b.
requirement for intravenous alimentation; c. prior surgical procedures affecting
absorption including total gastric resection; d. treatment for active peptic ulcer
disease in the past 6 months; e. 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; f.
6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4
inhibitors (see section 4.4, concomitant therapy).
7. Current use, or anticipated need for treatment with, drugs that are known CYP3A4
inducers or substrates for CYP1A2 (see section 4.4, 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: myocardial infarction,
uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive
heart failure, cerebrovascular accident or transient ischemic attack.
11. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive
12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
13. ALT or AST ≥ 1.5 x ULN; Bilirubin ≥ 1.5 x ULN.
14. Serum creatinine ≥ 1.5 x ULN
15. Neutrophil count < 1.0 x 109/L; platelet count < 100 x 109/L; Hb ≤ 90g/L.
16. Known severe hepatic impairment (Child-Pugh class C)
17. Known hypersensitivity to axitinib or any of its excipients. Specifically patients
with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption should not enter the study.
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