Clinical Trial: Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer

Brief Summary: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma.

II. Determine the response rate (complete response and partial response) in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. Determine the progression-free survival and response duration of patients treated with this regimen.

II. Correlate changes in laboratory parameters with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Overall response rate (CR+PR) using RECIST criteria [ Time Frame: Up to 5 years ]
    CR+PR rate will be calculated with exact 90% confidence intervals.
  • Grade 3+ toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ]
    Toxicities will be tabulated by type and grade. Toxicity rates will be calculated with exact 90% confidence intervals.
  • Progression-free survival [ Time Frame: Up to 5 years ]
    Kaplan-Meier curves will be used.
  • Overall survival [ Time Frame: Up to 5 years ]
    Kaplan-Meier curves will be used.
  • Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented , assessed up to 5 years ]
    Kaplan-Meier curves will be used.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 7, 2004
Date Started: October 2004
Date Completion:
Last Updated: July 1, 2013
Last Verified: July 2013