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A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02694536
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : January 10, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Erlotinib
Drug: Gemcitabine
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Period Title: Overall Study
Started 80
Completed 0
Not Completed 80
Reason Not Completed
Progressive Disease             40
Lost to Follow-up             1
Study Drug-Related Adverse Event             1
Withdrawal by Subject             8
Death             8
Not Specified             22
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
Safety Population: All participants who received at least one dose of erlotinib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
62.45  (10.299)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
32
  40.0%
Male
48
  60.0%
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Time Frame Up to approximately 40 months (assessed continuously during treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: percentage of participants
78.8
2.Secondary Outcome
Title European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Hide Description The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available.
Time Frame Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The "Number of Participants Analyzed" reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table.
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
Q1: Trouble in strenuous activities (n=256) 1.96  (0.758)
Q2: Trouble with long walk (n=259) 2.03  (0.802)
Q3: Trouble with short walk (n=258) 1.50  (0.696)
Q4: Need to say in bed or chair (n=255) 1.87  (0.699)
Q5: Need help in daily activities (n=259) 1.21  (0.501)
Q6: Limited in doing work/daily activities (n=257) 1.82  (0.803)
Q7: Limited in pursuing hobbies (n=255) 1.73  (0.798)
Q8: Short of breath (n=258) 1.38  (0.608)
Q9: Pain (n=257) 1.88  (0.771)
Q10: Need to rest (n=255) 2.05  (0.697)
Q11: Trouble sleeping (n=257) 1.74  (0.699)
Q12: Felt weak (n=255) 2.05  (0.774)
Q13: Lacked appetite (n=257) 1.70  (0.730)
Q14: Felt nauseated (n=257) 1.48  (0.679)
Q15: Vomited (n=259) 1.10  (0.414)
Q16: Constipated (n=259) 1.51  (0.723)
Q17: Diarrhea (n=259) 1.27  (0.496)
Q18: Tired (n=255) 2.07  (0.689)
Q19: Pain interference with daily activity (n=256) 1.69  (0.814)
Q20: Difficulty concentrating (n=257) 1.49  (0.638)
Q21: Felt tense (n=256) 1.97  (0.716)
Q22: Worried (n=253) 2.10  (0.773)
Q23: Felt irritable (n=258) 1.75  (0.707)
Q24: Felt depressed (n=258) 1.67  (0.658)
Q25: Difficulty remembering things (n=257) 1.44  (0.543)
Q26: Interference with family life (n=257) 1.59  (0.680)
Q27: Interference with social activities (n=257) 1.62  (0.772)
Q28: Financial difficulties (n=258) 1.32  (0.655)
Q29: Overall health (n=255) 4.44  (1.314)
Q30: Overall quality of life (n=255) 4.38  (1.346)
3.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description The percentage of participants who died from any cause was reported to the nearest integer.
Time Frame Up to approximately 40 months (assessed continuously through end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
73
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame Up to approximately 40 months (assessed continuously through end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 78
Median (95% Confidence Interval)
Unit of Measure: months
7.49
(5.42 to 9.04)
5.Secondary Outcome
Title Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.
Time Frame Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
88
6.Secondary Outcome
Title Progression-Free Survival (PFS) According to RECIST
Hide Description Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description:
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Overall Number of Participants Analyzed 78
Median (95% Confidence Interval)
Unit of Measure: months
4.864
(3.484 to 5.850)
Time Frame Up to approximately 40 months (assessed continuously during treatment)
Adverse Event Reporting Description Analysis Population Description: Safety Population.
 
Arm/Group Title Erlotinib + Gemcitabine
Hide Arm/Group Description Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
All-Cause Mortality
Erlotinib + Gemcitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib + Gemcitabine
Affected / at Risk (%)
Total   35/80 (43.75%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/80 (1.25%) 
Thrombocytopenia * 1  1/80 (1.25%) 
Melaena * 1  1/80 (1.25%) 
Cardiac disorders   
Cardiac arrest * 1  2/80 (2.50%) 
Myocardial infarction * 1  1/80 (1.25%) 
Gastrointestinal disorders   
Abdominal pain * 1  3/80 (3.75%) 
Intestinal obstruction * 1  1/80 (1.25%) 
Intestinal perforation * 1  1/80 (1.25%) 
Pancreatic carcinoma * 1  2/80 (2.50%) 
Peritonitis * 1  1/80 (1.25%) 
Vomiting * 1  1/80 (1.25%) 
Ileus * 1  1/80 (1.25%) 
General disorders   
Disease progression * 1  6/80 (7.50%) 
General physical health deterioration * 1  2/80 (2.50%) 
Ill-defined disorder * 1  1/80 (1.25%) 
Pyrexia * 1  1/80 (1.25%) 
Multi-organ failure * 1  1/80 (1.25%) 
Hepatobiliary disorders   
Hepatic failure * 1  2/80 (2.50%) 
Jaundice * 1  3/80 (3.75%) 
Hyperbilirubinaemia * 1  1/80 (1.25%) 
Infections and infestations   
Liver abscess * 1  1/80 (1.25%) 
Pneumonia * 1  2/80 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pancreatic carcinoma * 1  3/80 (3.75%) 
Nervous system disorders   
Cerebrovascular accident * 1  2/80 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/80 (1.25%) 
Pulmonary embolism * 1  1/80 (1.25%) 
Surgical and medical procedures   
Surgery * 1  1/80 (1.25%) 
Vascular disorders   
Deep vein thrombosis * 1  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib + Gemcitabine
Affected / at Risk (%)
Total   44/80 (55.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  21/80 (26.25%) 
Thrombocytopenia * 1  18/80 (22.50%) 
Leukopenia * 1  14/80 (17.50%) 
Neutropenia * 1  9/80 (11.25%) 
Gastrointestinal disorders   
Constipation * 1  5/80 (6.25%) 
Abdominal pain * 1  4/80 (5.00%) 
General disorders   
Pyrexia * 1  12/80 (15.00%) 
Asthenia * 1  4/80 (5.00%) 
Hepatobiliary disorders   
Hepatotoxicity * 1  5/80 (6.25%) 
Investigations   
Alanine aminotransferase increased * 1  5/80 (6.25%) 
Aspartate aminotransferase increased * 1  5/80 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02694536     History of Changes
Other Study ID Numbers: ML19537
2005-004605-29 ( EudraCT Number )
First Submitted: February 24, 2016
First Posted: February 29, 2016
Results First Submitted: September 12, 2016
Results First Posted: January 10, 2017
Last Update Posted: March 24, 2017