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.

Bayer

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Renal Cell

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00678288

CONCERT (Other Identifier)

12782

2007-005083-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Patient should be excluded if they have unresolved chronic toxicity grade
• > 1 and related to prior therapy with sunitinib.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Sorafenib (Nexavar, BAY43-9006) + Interferon

Experimental group

Description:

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.

Treatment:

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