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Phase III Randomized Study of Interferon alfa-2b With or Without Bevacizumab in Patients With Advanced Renal Cell Carcinoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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NCI
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CALGB-90206 CAN-NCIC-REC1, CALGB-90206, ECOG-CALGB-90206, NCT00072046, REC1
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Special Category:
CTSU trial 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.
Entry 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
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] Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- 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] Expected Enrollment A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years. 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. Published ResultsRini BI, Halabi S, Rosenberg JE, et al.: CALGB 90206: a phase III trial of bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in metastatic renal cell carcinoma. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-350, 2008. Rini BI, Halabi S, Taylor J, et al.: Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma. Clin Cancer Res 10 (8): 2584-6, 2004.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B | | | Brian Rini, MD, Protocol chair(Contact information may not be current) | | | |
NCIC-Clinical Trials Group | | | Simon Tanguay, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | Janice Dutcher, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma | | Trial Start Date | | 2003-10-01 | | Registered in ClinicalTrials.gov | | NCT00072046 | | Date Submitted to PDQ | | 2003-09-12 | | Information Last Verified | | 2006-08-04 | | NCI Grant/Contract Number | | CA31946 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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