This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination and select the doses of these drugs to be given in the second part of the trial. The purpose of the second part of the trial is to see if the combination of sunitinib malate given in combination with interferon alfa-2b is any better at delaying progression of renal cell cancer than sunitinib malate given alone in one of two dose schedules. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Condition	Intervention	Phase
Renal Cell Carcinoma	Drug: Sunitinib Malate Schedule 4/2  Drug: Sunitinib Malate Schedule 4/2 with Interferon Alfa-2b TIW  Drug: Sunitinib Malate Continuous Daily Dosing	Phase III

Further study details as provided by Pfizer:

Primary Outcomes: The primary objective for the randomized part of the trial is to compare the time to progression for sunitinib malate when given on Schedule 4/2 alone and in combination with interferon alfa-2b.
Secondary Outcomes: Secondary objectives: Evaluate safety and tolerability, time to progression, response rate, overall survival and quality of life of sunitinib malate when given in two dose schedules and in combination with interferon alfa-2b.
Expected Total Enrollment:  499

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
• Measurable disease

Exclusion Criteria:

• Prior systemic therapy of any kind for advanced renal cell cancer
• History of brain metastastes
• Uncontrolled hypertension

Please refer to this study by ClinicalTrials.gov identifier  NCT00267748

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A6181065
Last Updated:  December 21, 2005
Record first received:  December 20, 2005
ClinicalTrials.gov Identifier:  NCT00267748
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10