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 2TerminatedNCT00678288

Bayer16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Renal Cell

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (35)

Unnamed facility

Vienna, State of Vienna, Austria

Unnamed facility

Salzburg, Austria

Unnamed facility

Avignon, France

Unnamed facility

Bayonne, France

Unnamed facility

Bordeaux, France

Unnamed facility

Marseille, France

Unnamed facility

Marseille, France

Unnamed facility

Nantes, France

Unnamed facility

Paris, France

Unnamed facility

Paris, France

...and 25 more locations

Outcomes

Primary Outcomes

Progression-Free Survival

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.

Time frame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks

Secondary Outcomes

Response Rate

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 frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

Time to Progression

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.

Time frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

Duration of Response

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.

Time frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

Overall Survival

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.

Time frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks