A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

Phase 2

Terminated

Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon

Brief Summary: This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

Recruitment & Eligibility

Inclusion Criteria

Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
And/or patients who have discontinued sunitinib treatment at any point due to toxicity
Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Sorafenib (Nexavar, BAY43-9006)	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Sorafenib (Nexavar, BAY43-9006) + Interferon	Sorafenib (Nexavar, BAY43-9006) + Interferon	Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	From start of treatment of the first subject until 14 months later, assessed every 8 weeks	Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

Secondary Outcome Measures

Name	Time	Method
Response Rate	From start of treatment of the first subject until 14 months later, assessed every 8 Weeks	Response Rate was the best tumor response (confirmed Complete Response \[CR\], Partial Response \[PR\] or Stable Disease \[SD\]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time to Progression	From start of treatment of the first subject until 14 months later, assessed every 8 Weeks	Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Duration of Response	From start of treatment of the first subject until 14 months later, assessed every 8 Weeks	Duration of Response was the time from date of first response (Complete Response \[CR\] or Partial Response \[PR\]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
Overall Survival	From start of treatment of the first subject until 14 months later, assessed every 8 Weeks	Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.