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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782690
First Posted: February 4, 2013
Last Update Posted: October 13, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.

Condition
Pancreatic Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival stratified by rash [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Incidence and severity of rash [ Time Frame: 12 months ]
  • Safety: incidence of adverse events [ Time Frame: 12 months ]
  • Reasons for dose modification/withdrawals [ Time Frame: 12 months ]
  • Management of rash symptoms [ Time Frame: 12 months ]
  • Clinical effectiveness in patients with Eastern Oncology Group Performance Status (ECOG PS) 2 [ Time Frame: 12 months ]
  • Response rate [ Time Frame: 12 months ]
  • Time to disease progression [ Time Frame: 12 months ]
  • Treatment satisfaction assessed by patient questionnaire [ Time Frame: 12 months ]

Enrollment: 376
Study Start Date: March 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

  Eligibility

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.


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

Inclusion Criteria:

  • Adult patients, age >= 18 years
  • Patients with metastatic pancreatic cancer where investigators have decided to give a combination therapy Tarceva and gemcitabine according to Summary of Product Characteristics (SmPC)
  • Written and signed informed consent prior to onset of documentation

Exclusion Criteria:

  • Contraindications for Tarceva according to Summary of Products Characteristics (SmPC)
  Contacts and Locations
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
Germany
Köln, Germany, 50937
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01782690     History of Changes
Other Study ID Numbers: ML23024
First Submitted: January 31, 2013
First Posted: February 4, 2013
Last Update Posted: October 13, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic 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