A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00674973|
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : April 26, 2016
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Erlotinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2015|
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 received erlotinib 150 mg tablet orally once daily.
Other Name: Tarceva
Placebo Comparator: Placebo
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.
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
- Progression-Free Survival [ Time Frame: From the time of randomization until progression of disease or death (up to 30 months) ]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.
- Percentage of Participants With Best Overall Response Rate [ Time Frame: From the time of randomization until progression of disease or death (up to 30 months) ]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) [ Time Frame: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months) ]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 [ Time Frame: From the time of randomization until or death (up to 30 months) ]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) [ Time Frame: Up to 28 days after discontinuation of study drug (up to 30 months) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674973
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|Study Director:||Clinical Trials||Hoffmann-La Roche|