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.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Age = 18.
2. Histologically proven clear cell renal cell caricoma.
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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. For metastatic (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 prostate-specific antigen (PSA) is not rising.
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. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.
4. 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.
5. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine or pulmonary disease other than directly related to RCC.
6. 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. malabsorption syndromes.
7. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors.
8. Current use, or anticipated need for treatment with, drugs that are known CYP3A4 inducers or substrates for CYP1A2.
9. 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.
10. Active seizure disorder, spinal cord compression, or carcinomatous meningitis.
11. 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.
12. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment).
13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
14. ALT or AST = 1.5 x ULN; Bilirubin = 1.5 x ULN.
15. Serum creatinine = 1.5 x ULN.
16. Neutrophil count < 1.0 x 109/L; platelet count < 100 x 109/L; Hb = 900g/L.
17. Known severe hepatic impairment (Child-Pugh class C).
18. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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