Clinical trial NCT02694536: A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Official title: A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 40 months (assessed continuously during treatment)
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
timeFrame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
measure: Percentage of Participants Who Died
timeFrame: Up to approximately 40 months (assessed continuously through end of study)
measure: Overall Survival (OS)
timeFrame: Up to approximately 40 months (assessed continuously through end of study)
measure: Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
measure: Progression-Free Survival (PFS) According to RECIST
timeFrame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Other outcomes:
Locations:
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Pavia
country: Italy
state: Lombardia
city: Bari
country: Italy
state: Puglia
city: Catania
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Cona (Ferrara)
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: