NCT01158222

Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To determine the clinical outcome (response rate and overall progression-free survival) in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy. II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma. III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients and investigate the association between the VEGF -634 genotype and the occurrence of hypertension in sunitinib-treated RCC patients. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule may be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in the absence of unacceptable toxicity or RECIST-defined progressive disease.

Conditions

• Clear Cell Renal Cell Carcinoma
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given orally

Timeline

• Start date: 2010-08-18
• Primary completion: 2013-06-20
• Completion: 2017-02-01
• First posted: 2010-07-08
• Last updated: 2018-09-14
• Results posted: 2018-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study