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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01782690
First received: January 31, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational study will evaluate the impact of rash on survival of patient s with metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcit abine. Further, clinical effectiveness, efficacy and safety will be assessed. Da ta 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of rash [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reasons for dose modification/withdrawals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Management of rash symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical effectiveness in patients with Eastern Oncology Group Performance Status (ECOG PS) 2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Treatment satisfaction assessed by patient questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: March 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782690

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01782690     History of Changes
Other Study ID Numbers: ML23024
Study First Received: January 31, 2013
Last Updated: July 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (Bfarm)

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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 10, 2014