A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
bevacizumab
+ recombinant interferon alfa
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.732 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 493 locations
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesSee the locationHuntsville Hospital
Huntsville, United StatesCCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, United StatesHembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, United States