Status:
COMPLETED
Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT00072046
Start Date
October 1 2003
End Date
November 1 2012
Last Update
July 6 2016
Active Locations (493)
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1
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Huntsville Hospital
Huntsville, Alabama, United States, 35801
3
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259
4
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903