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.

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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.

View Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

732

Study ID:

NCT00072046

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

732

Study ID:

NCT00072046

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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