Phase 3
N=80
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02694536 ↗Enrolled (actual)
80
Serious AEs
43.8%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs) — 78.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erlotinib (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
78.8 | — |
| SECONDARY European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores |
1.96; 2.03; 1.50; 1.87; 1.21; 1.82 | — |
| SECONDARY Percentage of Participants Who Died |
73 | — |
| SECONDARY Overall Survival (OS) |
7.49 | — |
| SECONDARY Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) |
88 | — |
| SECONDARY Progression-Free Survival (PFS) According to RECIST |
4.864 | — |
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
Data sourced from ClinicalTrials.gov (NCT02694536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.