NCT01782690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

January 31, 2013

Results QC Date

May 11, 2017

Last Update Submit

October 12, 2017

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Number of Participants With Rash by Severity

    Up to 12 months

  • Number of Participants With Adverse Events (AEs)

    Up to 12 months

  • Number of Dose Modifications and Dose Withdrawals of Erlotinib

    Up to 12 months

  • Number of Dose Modifications and Dose Withdrawals of Gemcitabine

    Up to 12 months

  • Time of Onset of Rash After Start Erlotinib Treatment

    Up to 12 months

  • +7 more secondary outcomes

Study Arms (1)

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: erlotinibDrug: gemcitabine

Interventions

erlotinibDRUG

Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)

Also known as: Tarceva
Erlotinib plus Gemcitabine
gemcitabineDRUG

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

Erlotinib plus Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic pancreatic cancer

You may qualify if:

  • 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)

You may not qualify if:

  • Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum

Cologne, 50937, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32093649DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib HydrochlorideGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

March 31, 2012

Primary Completion

February 28, 2015

Study Completion

February 28, 2015

Last Updated

July 23, 2018

Results First Posted

July 23, 2018

Record last verified: 2017-10

Locations

DE(1)