Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00640978|
Recruitment Status : Terminated (Significant Adverse Effects - Futility)
First Posted : March 21, 2008
Results First Posted : September 27, 2011
Last Update Posted : June 25, 2012
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.
-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.
- Determine the progression-free survival (PFS).
- Determine the response rate (RR).
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: RAD001 Drug: Erlotinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Erlotinib + RAD001
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
30 mg orally weekly for 4 weeks
Other Name: Everolimus
150 mg by mouth daily for 28 Days
- Number of Participants Surviving at 6 Months [ Time Frame: 6 months ]Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640978
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Milind Javle, MD||M.D. Anderson Cancer Center|