An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: erlotinib
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erlotinib plus Gemcitabine<br>Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. | Drug: erlotinib<br>* Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)<br>* Other names: Tarceva;Drug: gemcitabine<br>* Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Stratified by Rash | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Rash by Severity | Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. | Up to 12 months | 
| Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 12 months | 
| Number of Dose Modifications and Dose Withdrawals of Erlotinib | Reported is the total number of dose modifications/withdrawals for erlotinib. | Up to 12 months | 
| Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Reported is the number of dose modifications/withdrawals for gemcitabine. | Up to 12 months | 
| Time of Onset of Rash After Start Erlotinib Treatment | Reported is the number of days from first erlotinib treatment to first rash onset. | Up to 12 months | 
| Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. | Up to 12 months | 
| Percentage of Participants With Best Overall Response | Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. | Up to 12 months | 
| Time to Disease Progression | Disease progression was defined in accordance with daily routine practice. | Up to 12 months | 
| Score in Patient Questionnaire: Possible Side Effects | Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 | 
| Score in Participant Questionnaire: What to Do in Case of Side Effect | Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 | 
| Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 | 
| Score in Participant Questionnaire: Quality of Life | Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 |