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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
Sponsor:
Collaborators:
Novartis
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: RAD001
Drug: Erlotinib
Enrollment 16
Recruitment Details Recruitment Period: March 2008 through January 20, 2009. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details Of the sixteen registered, one (1) participant was enrolled but did not receive the planned treatment.
Arm/Group Title Erlotinib + RAD001
Hide Arm/Group Description Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Erlotinib + RAD001
Hide Arm/Group Description Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
63
(34 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Number of Participants Surviving at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib + RAD001
Hide Arm/Group Description:
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
15
Time Frame Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib + RAD001
Hide Arm/Group Description Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
All-Cause Mortality
Erlotinib + RAD001
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib + RAD001
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib + RAD001
Affected / at Risk (%)
Total   16/16 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/16 (6.25%) 
Hemoglobin  1  1/16 (6.25%) 
Leukocytes  1  1/16 (6.25%) 
Lymphopenia  1  5/16 (31.25%) 
Eye disorders   
Dry eyes  1  1/16 (6.25%) 
Gastrointestinal disorders   
Abdominal Pain  1  5/16 (31.25%) 
Anorexia  2  6/16 (37.50%) 
Dehydration  1  3/16 (18.75%) 
Diarrhea  1  9/16 (56.25%) 
Distention/bloating  1  1/16 (6.25%) 
Gastrointestinal obstruction  1  1/16 (6.25%) 
Mucositis (oral)  1  2/16 (12.50%) 
Nausea  1  5/16 (31.25%) 
Stomatitis  1  1/16 (6.25%) 
Taste Alteration  1  1/16 (6.25%) 
Vomiting  1  3/16 (18.75%) 
General disorders   
Confusion  1  1/16 (6.25%) 
Dehyration  1  1/16 (6.25%) 
Dizziness  1  1/16 (6.25%) 
Fatigue  1  6/16 (37.50%) 
Fever without neutropenia  1  4/16 (25.00%) 
Mood Alteration (Anxiety)  1  2/16 (12.50%) 
Rigor/chills  1  1/16 (6.25%) 
Xerostoma  1  1/16 (6.25%) 
Infections and infestations   
Infection with normal neutrophils  1  2/16 (12.50%) 
Investigations   
Weight Loss  1  5/16 (31.25%) 
Metabolism and nutrition disorders   
Alkaline Phosphatase  1  5/16 (31.25%) 
Bilirubin  1  1/16 (6.25%) 
Cholesterol (serum high)  1  1/16 (6.25%) 
Hyperglycemia  1  3/16 (18.75%) 
Hyperkalemia  1  1/16 (6.25%) 
Hypertriglyceridemia  1  4/16 (25.00%) 
Hypoatremia  1  2/16 (12.50%) 
Hypokalemia  1  1/16 (6.25%) 
Serum glutamic oxaloacetic transaminase (AST, SGOT)  1  2/16 (12.50%) 
Serum glutamic pyruvic transaminase (ALT)  1  2/16 (12.50%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1  3/16 (18.75%) 
Pain (back)  1  2/16 (12.50%) 
Pain(joint)  1  1/16 (6.25%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  1/16 (6.25%) 
Yeast infection  1  2/16 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
Acne  1  7/16 (43.75%) 
Dry Skin  1  3/16 (18.75%) 
Rash (hand and foot eeaction)  1  1/16 (6.25%) 
Rash/Desquamation  1  2/16 (12.50%) 
Vascular disorders   
Thrombosis  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE 3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Milind Javle, MD/Associate Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-2828
EMail: mjlim@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00640978     History of Changes
Other Study ID Numbers: 2007-0666
First Submitted: March 17, 2008
First Posted: March 21, 2008
Results First Submitted: July 22, 2011
Results First Posted: September 27, 2011
Last Update Posted: June 25, 2012