A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
2 other identifiers
interventional
80
1 country
11
Brief Summary
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pancreatic-cancer
Started Aug 2006
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedResults Posted
Study results publicly available
January 10, 2017
CompletedMarch 24, 2017
February 1, 2017
3.3 years
February 24, 2016
September 12, 2016
February 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs)
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.
Up to approximately 40 months (assessed continuously during treatment)
Secondary Outcomes (5)
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
Percentage of Participants Who Died
Up to approximately 40 months (assessed continuously through end of study)
Overall Survival (OS)
Up to approximately 40 months (assessed continuously through end of study)
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Progression-Free Survival (PFS) According to RECIST
Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Study Arms (1)
Erlotinib + Gemcitabine
EXPERIMENTALParticipants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Interventions
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
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.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
- No prior systemic treatment for metastatic disease
- Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Life expectancy ≥12 weeks
- Adequate hematologic, hepatic, and renal function
- Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential
You may not qualify if:
- Unstable systemic disease
- Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
- Other malignancy within 5 years prior to study entry
- Significant opthalmologic abnormality
- Inability to take oral medication
- Need for IV alimentation
- Prior surgery affecting absorption
- Active peptic ulcer disease
- Nursing mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Bari, Apulia, 70124, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Pordenone, Friuli Venezia Giulia, 33170, Italy
Unknown Facility
Rome, Lazio, 00144, Italy
Unknown Facility
Pavia, Lombardy, 27100, Italy
Unknown Facility
Catania, Sicily, 95126, Italy
Unknown Facility
Pisa, Tuscany, 56100, Italy
Unknown Facility
Perugia, Umbria, 06156, Italy
Unknown Facility
Cona (Ferrara), Veneto, 44124, Italy
Unknown Facility
Verona, Veneto, 37126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
February 29, 2016
Study Start
August 1, 2006
Primary Completion
November 19, 2009
Study Completion
November 19, 2009
Last Updated
March 24, 2017
Results First Posted
January 10, 2017
Record last verified: 2017-02