Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

Phase 2

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: sorafenib tosylate

• Registration Number: NCT00866320
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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 how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Detailed Description

OBJECTIVES:

Primary

* To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate.

Secondary

* To determine the safety of sorafenib tosylate in these patients.

* To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-12-27
• Results First Submitted QC: 2011-12-27
• Results First Posted: 2012-02-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib	sorafenib tosylate	Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).

Primary Outcome Measures

Name	Time	Method
Tumor Burden Reduction Rate (TBRR)	at 8 weeks (2cycles of treatment)	The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.

Secondary Outcome Measures

Name	Time	Method
Time to Progression	followed to progression for approximately 3 years	Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.; Progression-free survival measured in months and summarized using the Kaplan-Meier method.
Duration of Overall Response (Tumor Burden Reduction)	followed for overall response for approximately 3 years	Measured 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.
Overall Survival	followed until progression or death for approximately 3 years	Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.

Trial Locations

Locations (2)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Baylor Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States