This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
PRIMARY OBJECTIVES: I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC. II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC. SECONDARY OBJECTIVES: I. Progression free survival. II. Duration of response. III. Overall Survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral sorafenib twice daily on days 1-28. Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28. In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity. Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping. After completion of study treatment, patients are followed every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Given orally 400 mg orally (PO) every 12 hours
Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10\^6 international units twice daily
Correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)
ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Time frame: Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.
Time frame: Up to 12 months of treatment
Progression-free Survival
Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Median Overall Survival (OS)
Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.
Time frame: From the start of protocol therapy to death or date of last follow-up, up to 36 months
Duration of Response for Participants With Stable Disease (N=37) Following Treatment
Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.
Time frame: From the date response is confirmed to the date of disease progression, up to 12 months
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