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Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00470535
Recruitment Status : Terminated (This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib)
First Posted : May 7, 2007
Results First Posted : December 10, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description Erlotinib 150mg orally daily for three weeks
Period Title: Overall Study
Started 18
Completed 0
Not Completed 18
Reason Not Completed
Disease Progression             13
Withdrawal by Subject             1
Adverse Event             1
Death             1
Other             2
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description Erlotinib 150mg orally daily for three weeks
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
65.6  (10.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Time Frame Every cycle for up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: months
1.4
(1.2 to 1.4)
2.Secondary Outcome
Title Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria
Hide Description [Not Specified]
Time Frame After every cycle
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Overall Survival
Hide Description [Not Specified]
Time Frame After every cycle
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy
Hide Description [Not Specified]
Time Frame Every 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation of Smoking Status With Overall Survival
Hide Description [Not Specified]
Time Frame Every 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade
Hide Description [Not Specified]
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description:
Erlotinib 150mg orally daily for three weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib (Tarceva)
Hide Arm/Group Description Erlotinib 150mg orally daily for three weeks
All-Cause Mortality
Erlotinib (Tarceva)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib (Tarceva)
Affected / at Risk (%) # Events
Total   9/18 (50.00%)    
Cardiac disorders   
Atrial fibrillation   1/18 (5.56%)  1
General disorders   
Asthenia   1/18 (5.56%)  1
Death   4/18 (22.22%)  4
Fatigue   1/18 (5.56%)  1
Pain   1/18 (5.56%)  1
Hepatobiliary disorders   
Bile duct obstruction   1/18 (5.56%)  1
Hepatic failure   1/18 (5.56%)  1
Infections and infestations   
Pneumonia   2/18 (11.11%)  2
Investigations   
Blood glucose   1/18 (5.56%)  1
Metabolism and nutrition disorders   
Decreased appetite   1/18 (5.56%)  1
Dehydration   2/18 (11.11%)  2
Failure to thrive   1/18 (5.56%)  1
Hypoalbuminaemia   1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Muscular weakness   1/18 (5.56%)  1
Psychiatric disorders   
Delirium   1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/18 (5.56%)  1
Pulmonary embolism   1/18 (5.56%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erlotinib (Tarceva)
Affected / at Risk (%) # Events
Total   17/18 (94.44%)    
Blood and lymphatic system disorders   
Anaemia   9/18 (50.00%)  17
Leukocytosis   1/18 (5.56%)  1
Lymphopenia   5/18 (27.78%)  6
Thrombocytopenia   3/18 (16.67%)  4
Eye disorders   
Vision blurred   1/18 (5.56%)  1
Gastrointestinal disorders   
Abdominal discomfort   1/18 (5.56%)  1
Abdominal pain   5/18 (27.78%)  5
Constipation   5/18 (27.78%)  6
Diarrhoea   8/18 (44.44%)  12
Dysphagia   2/18 (11.11%)  2
Nausea   7/18 (38.89%)  8
Small intestinal obstruction   1/18 (5.56%)  2
Stomatitis   1/18 (5.56%)  1
Vomiting   6/18 (33.33%)  6
General disorders   
Asthenia   1/18 (5.56%)  1
Chills   2/18 (11.11%)  2
Facial pain   1/18 (5.56%)  1
Fatigue   12/18 (66.67%)  16
Influenza like illness   1/18 (5.56%)  1
Non-cardiac chest pain   1/18 (5.56%)  1
Oedema   1/18 (5.56%)  2
Oedema peripheral   5/18 (27.78%)  5
Pain   2/18 (11.11%)  3
Hepatobiliary disorders   
Cholangiolitis   1/18 (5.56%)  2
Cholangitis   1/18 (5.56%)  1
Hyperbilirubinaemia   4/18 (22.22%)  6
Infections and infestations   
Nasopharyngitis   1/18 (5.56%)  1
Pneumonia   1/18 (5.56%)  1
Urinary tract infection   3/18 (16.67%)  5
Investigations   
Alanine aminotransferase   1/18 (5.56%)  1
Alanine aminotransferase increased   4/18 (22.22%)  5
Aspartate aminotransferase   1/18 (5.56%)  3
Aspartate aminotransferase increased   8/18 (44.44%)  13
Blood alkaline phosphatase   8/18 (44.44%)  12
Blood alkaline phosphatase increased   3/18 (16.67%)  3
Blood creatinine   1/18 (5.56%)  1
Blood creatinine increased   2/18 (11.11%)  2
Haemoglobin decreased   1/18 (5.56%)  1
International normalised ratio increased   2/18 (11.11%)  2
Platelet count decreased   1/18 (5.56%)  1
Prothrombin level abnormal   1/18 (5.56%)  2
Weight decreased   3/18 (16.67%)  4
Metabolism and nutrition disorders   
Decreased appetite   12/18 (66.67%)  12
Dehydration   5/18 (27.78%)  6
Hyperalbuminaemia   1/18 (5.56%)  1
Hypercalcaemia   1/18 (5.56%)  1
Hyperglycaemia   10/18 (55.56%)  24
Hyperkalaemia   2/18 (11.11%)  2
Hypernatraemia   5/18 (27.78%)  7
Hypoalbuminaemia   9/18 (50.00%)  18
Hypocalcaemia   1/18 (5.56%)  1
Hypoglycaemia   2/18 (11.11%)  3
Hypokalaemia   6/18 (33.33%)  9
Hyponatraemia   6/18 (33.33%)  8
Hypophosphataemia   1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Back pain   1/18 (5.56%)  1
Muscular weakness   3/18 (16.67%)  4
Nervous system disorders   
Dizziness   2/18 (11.11%)  2
Dysgeusia   3/18 (16.67%)  3
Headache   1/18 (5.56%)  1
Neuropathy peripheral   1/18 (5.56%)  1
Renal and urinary disorders   
Pollakiuria   1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   2/18 (11.11%)  2
Dysphonia   1/18 (5.56%)  1
Dyspnoea   2/18 (11.11%)  2
Epistaxis   1/18 (5.56%)  1
Hypoxia   1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Dermatitis acneiform   1/18 (5.56%)  1
Dry skin   2/18 (11.11%)  2
Palmar-plantar erythrodysaesthesia syndrome   1/18 (5.56%)  1
Pruritus   2/18 (11.11%)  2
Rash   7/18 (38.89%)  7
Rash macular   1/18 (5.56%)  1
Vascular disorders   
Hypotension   1/18 (5.56%)  1
Indicates events were collected by systematic assessment
This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib
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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470535     History of Changes
Other Study ID Numbers: CDR0000543406
RPCI-I-87106
First Submitted: May 3, 2007
First Posted: May 7, 2007
Results First Submitted: December 3, 2014
Results First Posted: December 10, 2014
Last Update Posted: February 23, 2017