Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced 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: NCT00674973
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : April 26, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Erlotinib
Drug: Placebo
Enrollment 207
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Period Title: Overall Study
Started 103 104
Switch to Open-Label Erlotinib 57 [1] 0
Completed 3 [2] 2 [2]
Not Completed 100 102
Reason Not Completed
Insufficient Therapeutic Response             77             72
Refused Treatment             1             5
Failure to Return             1             0
Adverse Event             2             9
Death             19             15
Protocol Violation             0             1
[1]
Participants with PD were given opportunity to switch.
[2]
Completed double-blind treatment.
Arm/Group Title Placebo Erlotinib Total
Hide Arm/Group Description Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death. Total of all reporting groups
Overall Number of Baseline Participants 103 104 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 104 participants 207 participants
Less than (<) 65 years 72 62 134
Greater than (>) 65 years 31 42 73
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 104 participants 207 participants
Female
44
  42.7%
45
  43.3%
89
  43.0%
Male
59
  57.3%
59
  56.7%
118
  57.0%
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.
Time Frame From the time of randomization until progression of disease or death (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description:
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Overall Number of Participants Analyzed 103 104
Median (95% Confidence Interval)
Unit of Measure: weeks
5.9
(5.4 to 6.1)
6.1
(5.9 to 6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib
Comments Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1909
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.63 to 1.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Best Overall Response Rate
Hide Description Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Time Frame From the time of randomization until progression of disease or death (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description:
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0
(0.0 to 3.5)
0
(0.0 to 3.5)
PR
4
(1.1 to 9.6)
1
(0.0 to 5.2)
3.Secondary Outcome
Title Percentage of Participants With Disease Control Rate (DCR)
Hide Description Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Time Frame Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description:
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19
(11.5 to 27.3)
29
(19.5 to 37.5)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Time Frame From the time of randomization until or death (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description:
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Overall Number of Participants Analyzed 103 104
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(2.1 to 4.3)
4.0
(2.8 to 4.8)
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Time Frame Up to 28 days after discontinuation of study drug (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population.
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description:
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
71 90
Time Frame Adverse events were assessed from baseline up to 28 days after discontinuation of study drug (up to 30 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Erlotinib
Hide Arm/Group Description Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
All-Cause Mortality
Placebo Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   11/103 (10.68%)   21/104 (20.19%) 
Blood and lymphatic system disorders     
ANAEMIA  1  0/103 (0.00%)  2/104 (1.92%) 
HAEMORRHAGIC ANAEMIA  1  0/103 (0.00%)  1/104 (0.96%) 
Gastrointestinal disorders     
ABDOMINAL PAIN LOWER  1  1/103 (0.97%)  0/104 (0.00%) 
DIARRHOEA  1  1/103 (0.97%)  0/104 (0.00%) 
DYSPHAGIA  1  0/103 (0.00%)  1/104 (0.96%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/103 (0.00%)  1/104 (0.96%) 
HAEMATEMESIS  1  1/103 (0.97%)  0/104 (0.00%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  0/103 (0.00%)  1/104 (0.96%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/103 (0.00%)  1/104 (0.96%) 
General disorders     
PYREXIA  1  0/103 (0.00%)  2/104 (1.92%) 
DEVICE OCCLUSION  1  0/103 (0.00%)  1/104 (0.96%) 
DRUG INTOLERANCE  1  0/103 (0.00%)  1/104 (0.96%) 
FATIGUE  1  0/103 (0.00%)  1/104 (0.96%) 
MUCOSAL INFLAMMATION  1  1/103 (0.97%)  0/104 (0.00%) 
Hepatobiliary disorders     
BILE DUCT OBSTRUCTION  1  0/103 (0.00%)  1/104 (0.96%) 
BILIARY DILATATION  1  0/103 (0.00%)  1/104 (0.96%) 
CHOLANGITIS  1  1/103 (0.97%)  0/104 (0.00%) 
CHOLANGITIS ACUTE  1  0/103 (0.00%)  1/104 (0.96%) 
HEPATIC FAILURE  1  0/103 (0.00%)  1/104 (0.96%) 
JAUNDICE CHOLESTATIC  1  1/103 (0.97%)  0/104 (0.00%) 
Infections and infestations     
BILIARY SEPSIS  1  0/103 (0.00%)  2/104 (1.92%) 
MORGANELLA INFECTION  1  0/103 (0.00%)  1/104 (0.96%) 
SEPSIS  1  0/103 (0.00%)  1/104 (0.96%) 
SEPTIC SHOCK  1  0/103 (0.00%)  1/104 (0.96%) 
Injury, poisoning and procedural complications     
ANASTOMOTIC ULCER  1  0/103 (0.00%)  1/104 (0.96%) 
CONCUSSION  1  1/103 (0.97%)  0/104 (0.00%) 
PROCEDURAL PAIN  1  0/103 (0.00%)  1/104 (0.96%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  0/103 (0.00%)  1/104 (0.96%) 
DEHYDRATION  1  1/103 (0.97%)  0/104 (0.00%) 
HYPERCALCAEMIA  1  0/103 (0.00%)  1/104 (0.96%) 
HYPOGLYCAEMIA  1  1/103 (0.97%)  0/104 (0.00%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  0/103 (0.00%)  1/104 (0.96%) 
ISCHAEMIC STROKE  1  0/103 (0.00%)  1/104 (0.96%) 
Psychiatric disorders     
ANXIETY  1  1/103 (0.97%)  0/104 (0.00%) 
Renal and urinary disorders     
HAEMATURIA  1  1/103 (0.97%)  0/104 (0.00%) 
RENAL FAILURE  1  1/103 (0.97%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
PLEURAL EFFUSION  1  1/103 (0.97%)  2/104 (1.92%) 
DYSPNOEA  1  1/103 (0.97%)  0/104 (0.00%) 
HYDROPNEUMOTHORAX  1  1/103 (0.97%)  0/104 (0.00%) 
PULMONARY EMBOLISM  1  0/103 (0.00%)  1/104 (0.96%) 
Vascular disorders     
VENOUS THROMBOSIS  1  1/103 (0.97%)  0/104 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   70/103 (67.96%)   81/104 (77.88%) 
Blood and lymphatic system disorders     
ANAEMIA  1  8/103 (7.77%)  11/104 (10.58%) 
Gastrointestinal disorders     
DIARRHOEA  1  23/103 (22.33%)  25/104 (24.04%) 
VOMITING  1  21/103 (20.39%)  13/104 (12.50%) 
NAUSEA  1  10/103 (9.71%)  22/104 (21.15%) 
ABDOMINAL PAIN  1  15/103 (14.56%)  16/104 (15.38%) 
CONSTIPATION  1  17/103 (16.50%)  8/104 (7.69%) 
ABDOMINAL PAIN UPPER  1  12/103 (11.65%)  10/104 (9.62%) 
ASCITES  1  9/103 (8.74%)  1/104 (0.96%) 
General disorders     
FATIGUE  1  12/103 (11.65%)  15/104 (14.42%) 
ASTHENIA  1  7/103 (6.80%)  12/104 (11.54%) 
PYREXIA  1  7/103 (6.80%)  12/104 (11.54%) 
MUCOSAL INFLAMMATION  1  1/103 (0.97%)  6/104 (5.77%) 
Investigations     
WEIGHT DECREASED  1  5/103 (4.85%)  11/104 (10.58%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  13/103 (12.62%)  18/104 (17.31%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  6/103 (5.83%)  3/104 (2.88%) 
Psychiatric disorders     
INSOMNIA  1  7/103 (6.80%)  2/104 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  9/103 (8.74%)  4/104 (3.85%) 
Skin and subcutaneous tissue disorders     
RASH  1  19/103 (18.45%)  48/104 (46.15%) 
DERMATITIS ACNEIFORM  1  2/103 (1.94%)  7/104 (6.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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: NCT00674973     History of Changes
Other Study ID Numbers: BO21129
2007-003738-40 ( EudraCT Number )
First Submitted: April 30, 2008
First Posted: May 8, 2008
Results First Submitted: March 24, 2016
Results First Posted: April 26, 2016
Last Update Posted: June 17, 2016