Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782690
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Drug: erlotinib Drug: gemcitabine

Layout table for study information
Study Type : Observational
Actual Enrollment : 338 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice
Study Start Date : March 31, 2012
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : February 28, 2015


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 Name: Tarceva

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




Primary Outcome Measures :
  1. Overall Survival Stratified by Rash [ Time Frame: Up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Rash by Severity [ Time Frame: Up to 12 months ]
    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.

  2. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 12 months ]
    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.

  3. Number of Dose Modifications and Dose Withdrawals of Erlotinib [ Time Frame: Up to 12 months ]
    Reported is the total number of dose modifications/withdrawals for erlotinib.

  4. Number of Dose Modifications and Dose Withdrawals of Gemcitabine [ Time Frame: Up to 12 months ]
    Reported is the number of dose modifications/withdrawals for gemcitabine.

  5. Time of Onset of Rash After Start Erlotinib Treatment [ Time Frame: Up to 12 months ]
    Reported is the number of days from first erlotinib treatment to first rash onset.

  6. Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) [ Time Frame: Up to 12 months ]
    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.

  7. Percentage of Participants With Best Overall Response [ Time Frame: Up to 12 months ]
    Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.

  8. Time to Disease Progression [ Time Frame: Up to 12 months ]
    Disease progression was defined in accordance with daily routine practice.

  9. Score in Patient Questionnaire: Possible Side Effects [ Time Frame: At Weeks 4, 8, 9 and 16 ]
    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.

  10. Score in Participant Questionnaire: What to Do in Case of Side Effect [ Time Frame: At Weeks 4, 8, 9 and 16 ]
    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.

  11. Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation [ Time Frame: At Weeks 4, 8, 9 and 16 ]
    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.

  12. Score in Participant Questionnaire: Quality of Life [ Time Frame: At Weeks 4, 8, 9 and 16 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic pancreatic cancer
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782690


Locations
Layout table for location information
Germany
Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum
Köln, Germany, 50937
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01782690     History of Changes
Other Study ID Numbers: ML23024
First Posted: February 4, 2013    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors