AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis. 2. Evidence of unidimensionally measurable disease (ie, >/=1 malignant tumor mass that can be accurately measured in at least 1 dimension >/= 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or >/=10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. 3. Must have progressive disease per RECIST (version 1.0) after one prior systemic first-line regimen for metastatic renal cell cancer. The prior regimen must have contained one or more of the following: sunitinib, bevacizumab + IFN ±, temsirolimus, or cytokine(s). 4. Adequate organ function as defined by the following criteria: - absolute neutrophil count (ANC) >/=1500 cells/mm3; - platelets >/=75,000 cells/mm3. - Hemoglobin >/=9.0 g/dl. - AST and ALT /=60 mL/min; - Urinary protein <2+ by urine dipstick. If 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. 5. Male or female, age >/=18 years. 6. ECOG performance status of 0 or 1. 7. Life expectancy of >/=12 weeks. 8. At least 2 weeks since the end of prior systemic treatment (4 weeks for bevacizumab + IFN ±), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 3.0 grade 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment of mRCC with more than one systemic first-line regimen. 2. Patients treated with any neoadjuvant or adjuvant systemic therapy. 3. Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated. 4. Gastrointestinal abnormalities including: - inability to take oral medication; - requirement for intravenous alimentation; - prior surgical procedures affecting absorption including total gastric resection; - treatment for active peptic ulcer disease in the past 6 months;- 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; - malabsorption syndromes. 5. 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, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine). 6. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St.John s wort). 7. 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. 8. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 9. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment. 10. 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. 11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 12. History of a malignancy (other than renal cell cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years. 13. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 14. Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate. 15. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participat

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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