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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: erlotinib; Drug: gemcitabine

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• Germany
  • Köln, Germany, 50937
    • Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with metastatic pancreatic cancer

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Westphalen CB, Kukiolka T, Garlipp B, Hahn L, Fuchs M, Malfertheiner P, Reiser M, Kutting F, Heinemann V, Beringer A, Waldschmidt DT. Correlation of skin rash and overall survival in patients with pancreatic cancer treated with gemcitabine and erlotinib - results from a non-interventional multi-center study. BMC Cancer. 2020 Feb 24;20(1):155. doi: 10.1186/s12885-020-6636-7.

Study record dates

Study Major Dates

• Study Start: March 31, 2012
• Primary Completion (Actual): February 28, 2015
• Study Completion (Actual): February 28, 2015

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Gemcitabine; Erlotinib Hydrochloride
• Other Study ID Numbers: ML23024