NCT00496756

Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma. Secondary * Determine tumor response in these patients. * Determine time to progression in these patients. * Determine overall survival of these patients. Tertiary * Collect data on angiogenesis inhibition induced by sorafenib tosylate. * Collect data on immunomodulatory effects of sorafenib tosylate. OUTLINE: This is an open-label study. Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4 dose-limiting toxicity) until a pre-determined dose is reached. Blood and urine samples are collected at baseline and periodically during study for VEGF level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-10-31
• Completion: 2014-04-25
• First posted: 2007-07-04
• Last updated: 2023-10-26
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study