N/A
Completed N=338
An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT01782690 ↗Enrolled (actual)
338
Serious AEs
50.6%
Results posted
Jul 2018
Primary outcomePrimary: Overall Survival Stratified by Rash — 9.9288; 8.6795 months — p=0.2361
Summary
This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Stratified by Rash |
9.9288; 8.6795 | 0.2361 |
| SECONDARY Number of Participants With Rash by Severity |
174; 10; 7; 2; 62; 26 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
310 | — |
| SECONDARY Number of Dose Modifications and Dose Withdrawals of Erlotinib |
152 | — |
| SECONDARY Number of Dose Modifications and Dose Withdrawals of Gemcitabine |
738 | — |
| SECONDARY Time of Onset of Rash After Start Erlotinib Treatment |
18.4 | — |
| SECONDARY Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) |
9.8301; 6.3452 | — |
| SECONDARY Percentage of Participants With Best Overall Response |
24.74 | — |
| SECONDARY Time to Disease Progression |
4.3726 | — |
| SECONDARY Score in Patient Questionnaire: Possible Side Effects |
1.9; 1.9; 1.0; 1.9 | — |
| SECONDARY Score in Participant Questionnaire: What to Do in Case of Side Effect |
1.9; 2.0; 1.0; 1.9 | — |
| SECONDARY Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation |
2.6; 2.6; 6.0; 2.7 | — |
| SECONDARY Score in Participant Questionnaire: Quality of Life |
2.9; 2.9; 1.0; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adults, age >= 18 years
- Patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to Summary of Product Characteristics (SmPC)
Exclusion Criteria
- Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)
Data sourced from ClinicalTrials.gov (NCT01782690). 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. Informational only — not medical advice.