Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC
|ClinicalTrials.gov Identifier: NCT00522249|
Recruitment Status : Terminated (PI decision)
First Posted : August 29, 2007
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Pegylated Alfa Interferon Drug: sunitinib Drug: erlotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||July 2008|
One cycle of the combination therapy will be 42 days (6 weeks). All patients will receive PEG-Intron given subcutaneously on Day 1 each week. Patients will receive Sunitinib orally on Days 1-28 of each cycle. Patients will receive Tarceva orally on Days 1-42.
Drug: Pegylated Alfa Interferon
Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level.
Other Names:Drug: sunitinib
Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level.
Other Name: Sutent®Drug: erlotinib
Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration.
Other Name: Tarceva®
- Time to progression Objective response rate [ Time Frame: every 6 wks ]
- Overall survival [ Time Frame: every 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522249
|United States, Texas|
|Baylor College of Medicine - Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||The Methodist Hospital Research Institute|