A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02694536|
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : January 10, 2017
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Erlotinib Drug: Gemcitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer|
|Study Start Date :||August 1, 2006|
|Actual Primary Completion Date :||November 19, 2009|
|Actual Study Completion Date :||November 19, 2009|
Experimental: Erlotinib + Gemcitabine
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
Other Name: Tarceva
Participants will receive gemcitabine 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.
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 40 months (assessed continuously during treatment) ]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.
- European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study) ]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.
- Percentage of Participants Who Died [ Time Frame: Up to approximately 40 months (assessed continuously through end of study) ]The percentage of participants who died from any cause was reported to the nearest integer.
- Overall Survival (OS) [ Time Frame: Up to approximately 40 months (assessed continuously through end of study) ]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.
- Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) ]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.
- Progression-Free Survival (PFS) According to RECIST [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) ]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.
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): NCT02694536
|Napoli, Campania, Italy, 80131|
|Bologna, Emilia-Romagna, Italy, 40138|
|Pordenone, Friuli-Venezia Giulia, Italy, 33170|
|Roma, Lazio, Italy, 00144|
|Pavia, Lombardia, Italy, 27100|
|Bari, Puglia, Italy, 70124|
|Catania, Sicilia, Italy, 95126|
|Pisa, Toscana, Italy, 56100|
|Perugia, Umbria, Italy, 06156|
|Cona (Ferrara), Veneto, Italy, 44124|
|Verona, Veneto, Italy, 37126|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|