Clinical trial NCT01782690: An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic pancreatic cancer

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.


Eligibility 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)

Primary outcomes:
measure: Overall Survival Stratified by Rash
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of Participants With Rash by Severity
timeFrame: Up to 12 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Number of Dose Modifications and Dose Withdrawals of Erlotinib
timeFrame: Up to 12 months
measure: Number of Dose Modifications and Dose Withdrawals of Gemcitabine
timeFrame: Up to 12 months
measure: Time of Onset of Rash After Start Erlotinib Treatment
timeFrame: Up to 12 months
measure: Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
timeFrame: Up to 12 months
measure: Percentage of Participants With Best Overall Response
timeFrame: Up to 12 months
measure: Time to Disease Progression
timeFrame: Up to 12 months
measure: Score in Patient Questionnaire: Possible Side Effects
timeFrame: At Weeks 4, 8, 9 and 16
measure: Score in Participant Questionnaire: What to Do in Case of Side Effect
timeFrame: At Weeks 4, 8, 9 and 16
measure: Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
timeFrame: At Weeks 4, 8, 9 and 16
measure: Score in Participant Questionnaire: Quality of Life
timeFrame: At Weeks 4, 8, 9 and 16
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.