An Observational Study of Tarceva (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. Identifier: NCT01782690
Recruitment Status : Completed
First Posted : February 4, 2013
Last Update Posted : November 2, 2016
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 Tarceva (erlotinib) plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.

Condition or disease
Pancreatic Cancer

Study Type : Observational
Actual Enrollment : 376 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 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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

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

Information from the National Library of Medicine

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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

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)

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 identifier (NCT number): NCT01782690

Köln, Germany, 50937
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01782690     History of Changes
Other Study ID Numbers: ML23024
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
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