Kidney Cancer Clinical Trial
Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Summary
RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer).
PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.
Full Description
OBJECTIVES:
Primary
Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab.
Secondary
Compare the time to disease progression and objective response rates in patients treated with these regimens.
Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week.
Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry.
PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.