Back to resultsA Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erlotinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
- measurable disease according to RECIST;
- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
- ECOG performance status of 0-2.
Exclusion Criteria:
- local or locally advanced-resectable pancreatic cancer;
- any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- major surgery within 2 weeks prior to randomization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Erlotinib
Placebo
Arm 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 erlotinib 150 mg orally once daily until disease progression, 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 placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Outcomes
Primary Outcome Measures
Progression-Free Survival
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.
Secondary Outcome Measures
Percentage of Participants With Best Overall Response Rate
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.
Percentage of Participants With Disease Control Rate (DCR)
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.
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Number of Participants With Adverse Events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00674973
Brief Title
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Official Title
A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib
Arm Type
Experimental
Arm 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 erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Participants received erlotinib 150 mg tablet orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
Primary Outcome Measure Information:
Title
Progression-Free Survival
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Best Overall Response Rate
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)
Title
Percentage of Participants With Disease Control Rate (DCR)
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)
Title
Overall Survival
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)
Title
Number of Participants With Adverse Events (AEs)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
measurable disease according to RECIST;
failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
ECOG performance status of 0-2.
Exclusion Criteria:
local or locally advanced-resectable pancreatic cancer;
any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
major surgery within 2 weeks prior to randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Salvador, Bahia
State/Province
BA
ZIP/Postal Code
40170-380
Country
Brazil
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30110-0090
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
City
Jau
State/Province
SP
ZIP/Postal Code
17210-080
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05652-000
Country
Brazil
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
City
Vratza
ZIP/Postal Code
3000
Country
Bulgaria
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Bangalore
ZIP/Postal Code
560029
Country
India
City
Chennai
ZIP/Postal Code
600035
Country
India
City
Jaipur
ZIP/Postal Code
302004
Country
India
City
Kochi
ZIP/Postal Code
682304
Country
India
City
Kolkata
ZIP/Postal Code
700053
Country
India
City
Ludhiana
ZIP/Postal Code
141 001
Country
India
City
Mumbai
ZIP/Postal Code
400012
Country
India
City
New Delhi
ZIP/Postal Code
110076
Country
India
City
Pune
ZIP/Postal Code
411 001
Country
India
City
Vellore
ZIP/Postal Code
632004
Country
India
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
City
Penang
ZIP/Postal Code
11200
Country
Malaysia
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
City
Chiclayo
ZIP/Postal Code
CIX
Country
Peru
City
San Isidro
ZIP/Postal Code
L27 Lima
Country
Peru
City
Bucharest
Country
Romania
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
City
Craiova (Dolj county)
ZIP/Postal Code
200535
Country
Romania
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
City
Kiev
ZIP/Postal Code
36022
Country
Ukraine
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24827134
Citation
Propper D, Davidenko I, Bridgewater J, Kupcinskas L, Fittipaldo A, Hillenbach C, Klughammer B, Ducreux M. Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma. Ann Oncol. 2014 Jul;25(7):1384-1390. doi: 10.1093/annonc/mdu176. Epub 2014 May 14.
Results Reference
derived
Learn more about this trial
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
We'll reach out to this number within 24 hrs