Clinical trialObsCompleted
An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice
- Outcome
- Outcome unknown
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- 31 March 2012
- Expected end
- 28 February 2015
- Enrollment
- 338 participants
- Sites
- 1
- Primary outcomes
- Overall Survival Stratified by Rash
- Sponsor
- Industry
- Results posted
- 2018-07-23
- Last update
- 23 July 2018
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival Stratified by Rash [Up to 12 months]. Median, months (95% Confidence Interval). Rash = Yes: Erlotinib Plus Gemcitabine (n=270): 9.9288 (7.9562 to NA) [N/A=Not Available: Upper Limit not estimable]. Rash = No: Erlotinib Plus Gemcitabine (n=270): 8.6795 (7.2658 to NA) [N/A=Not Available: Upper Limit not estimable]. Analysis, Erlotinib Plus Gemcitabine: p=0.2361; Log Rank; superiority or other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Rash by Severity [Up to 12 months]. Number, participants. Total number with rash: Erlotinib Plus Gemcitabine (n=338): 174. Paronychia Grade 1: Erlotinib Plus Gemcitabine (n=338): 10. Paronychia Grade 2: Erlotinib Plus Gemcitabine (n=338): 7. Paronychia Grade 3: Erlotinib Plus Gemcitabine (n=338): 2. Dry skin Grade 1: Erlotinib Plus Gemcitabine (n=338): 62. Dry skin Grade 2: Erlotinib Plus Gemcitabine (n=338): 26. Papulopustulous eczema Grade 1: Erlotinib Plus Gemcitabine (n=338): 89. Papulopustulous eczema Grade 2: Erlotinib Plus Gemcitabine (n=338): 69. Papulopustulous eczema Grade 3: Erlotinib Plus Gemcitabine (n=338): 6.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events (AEs) [Up to 12 months]. Number, participants. Erlotinib Plus Gemcitabine (n=338): 310.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Dose Modifications and Dose Withdrawals of Erlotinib [Up to 12 months]. Number, dose modifications/withdrawals. Erlotinib Plus Gemcitabine (n=338): 152.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Dose Modifications and Dose Withdrawals of Gemcitabine [Up to 12 months]. Number, dose modifications/withdrawals. Erlotinib Plus Gemcitabine (n=338): 738.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time of Onset of Rash After Start Erlotinib Treatment [Up to 12 months]. Mean, days (Standard Deviation). Erlotinib Plus Gemcitabine (n=338): 18.4 (21.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) [Up to 12 months]. Median, months (95% Confidence Interval). ECOG-PS grade 0-1: Erlotinib Plus Gemcitabine (n=270): 9.8301 (8.2192 to NA) [N/A=Not Available: Upper Limit not estimable]. ECOG-PS grade 2: Erlotinib Plus Gemcitabine (n=270): 6.3452 (4.0110 to NA) [N/A=Not Available: Upper Limit not estimable].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants With Best Overall Response [Up to 12 months]. Number, percentage of participants. Erlotinib Plus Gemcitabine (n=270): 24.74.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Disease Progression [Up to 12 months]. Median, months (95% Confidence Interval). Erlotinib Plus Gemcitabine (n=270): 4.3726 (3.8795 to 5.0630).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Score in Patient Questionnaire: Possible Side Effects [At Weeks 4, 8, 9 and 16]. Mean, scores on a scale (Standard Deviation). Week 4: Erlotinib Plus Gemcitabine (n=338): 1.9 (0.9). Week 8: Erlotinib Plus Gemcitabine (n=338): 1.9 (0.9). Week 9: Erlotinib Plus Gemcitabine (n=338): 1.0 (NA) [Data based on one participant and therefore standard deviation not available.]. Week 16: Erlotinib Plus Gemcitabine (n=338): 1.9 (0.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Score in Participant Questionnaire: What to Do in Case of Side Effect [At Weeks 4, 8, 9 and 16]. Mean, scores on a scale (Standard Deviation). Week 4: Erlotinib Plus Gemcitabine (n=338): 1.9 (0.8). Week 8: Erlotinib Plus Gemcitabine (n=338): 2.0 (1.0). Week 9: Erlotinib Plus Gemcitabine (n=338): 1.0 (NA) [Data based on one participant and therefore standard deviation not available.]. Week 16: Erlotinib Plus Gemcitabine (n=338): 1.9 (0.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation [At Weeks 4, 8, 9 and 16]. Mean, scores on a scale (Standard Deviation). Week 4: Erlotinib Plus Gemcitabine (n=338): 2.6 (1.1). Week 8: Erlotinib Plus Gemcitabine (n=338): 2.6 (1.1). Week 9: Erlotinib Plus Gemcitabine (n=338): 6.0 (NA) [Data based on one participant and therefore standard deviation not available.]. Week 16: Erlotinib Plus Gemcitabine (n=338): 2.7 (1.1).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Score in Participant Questionnaire: Quality of Life [At Weeks 4, 8, 9 and 16]. Mean, scores on a scale (Standard Deviation). Week 4: Erlotinib Plus Gemcitabine (n=338): 2.9 (1.1). Week 8: Erlotinib Plus Gemcitabine (n=338): 2.9 (1.2). Week 9: Erlotinib Plus Gemcitabine (n=338): 1.0 (NA) [Data based on one participant and therefore standard deviation not available.]. Week 16: Erlotinib Plus Gemcitabine (n=338): 2.9 (1.1).