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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782690
• Other study ID #: ML23024
• Status: Completed
• Start date: March 31, 2012
• Est. completion date: February 28, 2015

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: February 28, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• erlotinib
Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)
• gemcitabine
Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)

Locations

Country	Name	City	State
Germany	Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Dose Modifications and Dose Withdrawals of Erlotinib	Reported is the total number of dose modifications/withdrawals for erlotinib.	Up to 12 months
Secondary	Number of Dose Modifications and Dose Withdrawals of Gemcitabine	Reported is the number of dose modifications/withdrawals for gemcitabine.	Up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to Disease Progression	Disease progression was defined in accordance with daily routine practice.	Up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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