Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer

Exclusion Criteria

• •Patients must have measurable disease; soft tissue disease, which has been radiated in the 2 months prior to registration, is not assessable as measurable disease; X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measureable disease must have been completed within 42 days prior to registration; all disease must be assessed
• •Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
• •Patients must not have received any prior systemic therapy for renal cell carcinoma, including chemotherapy, interferon, interleukin-2, other biologic response modifiers, anti-angiogenic therapy, hormonal therapy, or any other experimental systemic therapy; prior treatment with thyroid medications is allowed
• •Patients may have received prior radiation therapy to less than 25% of the bone marrow; at least 28 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
• •Total bilirubin =\< institutional upper limit of normal
• •SGOT or SGPT =\< 2.5 x institutional upper limit of normal
• •Serum creatinine =\< institutional upper limit of normal or calculated creatinine clearance \>= 60 mL/min for patients with creatinine levels above institutional normal
• •* Patients who have had a prior nephrectomy must have a serum creatinine =\< 2 x institutional upper limit of normal
• •Patients must be offered the opportunity to consent for specimen submission
• •Patients must have a Zubrod performance status of 0-1
• •Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical and/or inhaled steroids are allowed
• •Patients must be able to take oral medication without crushing, dissolving or chewing tablets
• •The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• •If Day 28, 42, or 56 falls on a weekend or holiday, the limit may be extended to the next working day
• •All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• •At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database