A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma

Date de début de l'étude : 1 octobre 2003

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma (RCC) * Conventional clear cell carcinoma * Metastatic or unresectable disease * The following characteristics and cellular types are excluded: * True papillary * Sarcomatoid features without a clear cell component * Chromophobe * Oncocytoma * Collecting duct tumor * Transitional cell carcinoma * Measurable or nonmeasurable disease, including any of the following: * Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI * The following are considered nonmeasurable disease: * Small lesions * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Irradiated lesions, unless progression is documented after radiotherapy * RCC paraffin tissue blocks or unstained slides must be available * No evidence of prior or concurrent CNS metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No history of clinically significant bleeding Hepatic * AST/ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN * No proteinuria \> 1+ * Proteinuria ≥ 2+ allowed provided protein is \< 2 g/24-hour urine collection Cardiovascular * No deep venous thrombosis within the past year * No cerebrovascular accident within the past year * No peripheral vascular disease with claudication on \< 1 block * No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication * No New York Heart Association class II-IV congestive heart failure * No angina pectoris requiring nitrate therapy * No myocardial infarction within the past 6 months * No other significant cardiovascular disease Pulmonary * No pulmonary embolus within the past year * No ongoing hemoptysis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication * No delayed wound healing, ulcers, or bone fractures * No uncontrolled psychiatric disorder * No other currently active\* malignancy except nonmelanoma skin cancer NOTE: \*Disease is not considered currently active if patient completed anticancer therapy and is considered to have \< 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic immunotherapy for RCC * No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No prior systemic chemotherapy for RCC * No concurrent chemotherapy Endocrine therapy * No concurrent systemic corticosteroid therapy except the following: * Topical and inhaled steroids * Replacement therapy for adrenal insufficiency * No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated * No concurrent palliative radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered Other * No other prior systemic investigational therapy for RCC * No other prior adjuvant or neoadjuvant systemic therapy for RCC * No concurrent full-dose oral or parenteral anticoagulation\* NOTE: \*Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowed