Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01263769
Eligibility Criteria:
Inclusion Criteria:
1. Locally advanced renal cell carcinoma without evidence of metastatic disease with absence of adjacent organ invasion or retroperitoneal adenopathy (cT2-T3b, N0, M0). Patients with retroperitoneal lymph nodes \</= 2cm in size each are considered N0.
2. Predominant clear cell histology on pre-treatment biopsy of the primary tumor.
3. Patient should be candidate for curative radical nephrectomy.
4. ECOG Performance Status 0-1.
5. Patient must provide signed informed consent.
6. Male or female, age \>/= 18 years.
7. Adequate renal function: serum creatinine level \</=1.5 x ULN or calculated creatinine clearance (as estimated by GFR using the MDRD formula) is \>/= 60 ml/min.
8. Adequate hepatic function: alkaline phosphatase \</= 1.5 x ULN; total bilirubin, AST, and ALT \</= 1.5 x ULN; INR \<1.3 (or \<3 if on anticoagulant therapy).
9. Adequate bone marrow function: ANC \>/= 1.5 x 10/ 9L; Platelets \>/= 100 x 109/L; Hb \>9 g/dL
10. Urinary protein \<100 on urinalysis (equivalent to \<2+ by urine dipstick). If urinalysis protein \>/=100 (equivalent to dipstick is \>/=2+) then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \<2 g per 24 hours
11. No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior to current study enrollment.
12. Women of childbearing potential (defined as a female subject who is not surgically sterilized, not at least 1 year postmenopausal) must have negative urine or serum pregnancy test within 4 weeks of enrollment and again on the day of starting therapy and she and/or her partner must utilize birth control while on therapy.
13. Male (defined as a male subject who has not been surgically sterilized) or female patients of child-producing potential must agree to use adequate contraception (e.g. IUD, condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: as of date of study enrollment and for at least 1 month after last dose of axitinib. Subjects who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
Exclusion Criteria:
1. Evidence of metastatic disease, adjacent organ invasion, retroperitoneal adenopathy on pre-treatment imaging. In addition, patients with inferior vena cava thrombi extending to the atrium or with evidence of Budd-Chiari Syndrome (hepatic dysfunction) will not be eligible for the protocol.
2. Patients who undergo embolization of their primary tumor.
3. Previous treatment for their primary renal tumor, including prior chemotherapy, immunotherapy, targeted therapy, radiation therapy, cryotherapy, radiofrequency ablation or embolization.
4. Active malignancies other than renal cell carcinoma and/or history of other malignancy within the last 5 years, except for adequately treated cone-biopsied in situ carcinoma of the cervix or basal or squamous cell carcinoma of the skin
5. Uncontrolled hypertension (BP\>140/90 on medications), as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be \</=140 mm Hg, and the baseline diastolic blood pressure readings must be \</=90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
7. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
8. Active gastrointestinal bleeding.
9. Malabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome.
10. Known HIV or Hepatitis C status.
11. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
12. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
13. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
14. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism
15. Withdrawal of consent.
16. Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01263769
Study Brief:
Protocol Section:
NCT01263769