An observational study in Pancreatic Cancer, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by Hoffmann-La Roche · Observational
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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 338 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with metastatic pancreatic cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Drug: erlotinib · Drug: gemcitabine
Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)
Also known as: Tarceva
Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)
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.
Time frame: Up to 12 months
Number of Participants With Rash by Severity
Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Time frame: Up to 12 months
Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to 12 months
Number of Dose Modifications and Dose Withdrawals of Erlotinib
Reported is the total number of dose modifications/withdrawals for erlotinib.
Time frame: Up to 12 months
Number of Dose Modifications and Dose Withdrawals of Gemcitabine
Reported is the number of dose modifications/withdrawals for gemcitabine.
Time frame: Up to 12 months
Time of Onset of Rash After Start Erlotinib Treatment
Reported is the number of days from first erlotinib treatment to first rash onset.
Time frame: Up to 12 months
Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time frame: Up to 12 months
Percentage of Participants With Best Overall Response
Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.
Time frame: Up to 12 months
Time to Disease Progression
Disease progression was defined in accordance with daily routine practice.
Time frame: Up to 12 months
Score in Patient Questionnaire: Possible Side Effects
Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Score in Participant Questionnaire: What to Do in Case of Side Effect
Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Score in Participant Questionnaire: Quality of Life
Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
| Milestone | Erlotinib Plus Gemcitabine |
|---|---|
| Started | 338 |
| Completed | 39 |
| Not completed | 299 |
| Withdrew: Not reported | 7 |
| Withdrew: Toxicity of gemcitabine | 1 |
| Withdrew: Toxicity of erlotinib | 1 |
| Withdrew: Lost to follow-up | 31 |
| Withdrew: Withdrawal of informed consent | 2 |
| Withdrew: Absent rash | 9 |
| Withdrew: Physician decision | 13 |
| Withdrew: Patient's wish | 21 |
| Withdrew: Tumor progression | 74 |
| Withdrew: Death | 133 |
| Withdrew: Study completion unknown | 7 |
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.
| months | Erlotinib Plus Gemcitabine |
|---|---|
| Rash = Yes | 9.9288 ± 0.5066 |
| Rash = No | 8.6795 ± 0.3151 |
Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
| participants | Erlotinib Plus Gemcitabine |
|---|---|
| Total number with rash | 174 |
| Paronychia Grade 1 | 10 |
| Paronychia Grade 2 | 7 |
| Paronychia Grade 3 | 2 |
| Dry skin Grade 1 | 62 |
| Dry skin Grade 2 | 26 |
| Papulopustulous eczema Grade 1 | 89 |
| Papulopustulous eczema Grade 2 | 69 |
| Papulopustulous eczema Grade 3 | 6 |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| participants | Erlotinib Plus Gemcitabine |
|---|---|
| Number of Participants With Adverse Events (AEs) | 310 |
Reported is the total number of dose modifications/withdrawals for erlotinib.
| dose modifications/withdrawals | Erlotinib Plus Gemcitabine |
|---|---|
| Number of Dose Modifications and Dose Withdrawals of Erlotinib | 152 |
Reported is the number of dose modifications/withdrawals for gemcitabine.
| dose modifications/withdrawals | Erlotinib Plus Gemcitabine |
|---|---|
| Number of Dose Modifications and Dose Withdrawals of Gemcitabine | 738 |
Reported is the number of days from first erlotinib treatment to first rash onset.
| days | Erlotinib Plus Gemcitabine |
|---|---|
| Time of Onset of Rash After Start Erlotinib Treatment | 18.4 ± 21.6 |
Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
| months | Erlotinib Plus Gemcitabine |
|---|---|
| ECOG-PS grade 0-1 | 9.8301 ± 0.3726 |
| ECOG-PS grade 2 | 6.3452 ± 0.7396 |
Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.
| percentage of participants | Erlotinib Plus Gemcitabine |
|---|---|
| Percentage of Participants With Best Overall Response | 24.74 |
Disease progression was defined in accordance with daily routine practice.
| months | Erlotinib Plus Gemcitabine |
|---|---|
| Time to Disease Progression | 4.3726 ± 0.2945 |
Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
| scores on a scale | Erlotinib Plus Gemcitabine |
|---|---|
| Week 4 | 1.9 ± 0.9 |
| Week 8 | 1.9 ± 0.9 |
| Week 9 | 1.0 ± NA |
| Week 16 | 1.9 ± 0.9 |
Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
| scores on a scale | Erlotinib Plus Gemcitabine |
|---|---|
| Week 4 | 1.9 ± 0.8 |
| Week 8 | 2.0 ± 1.0 |
| Week 9 | 1.0 ± NA |
| Week 16 | 1.9 ± 0.7 |
Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.
| scores on a scale | Erlotinib Plus Gemcitabine |
|---|---|
| Week 4 | 2.6 ± 1.1 |
| Week 8 | 2.6 ± 1.1 |
| Week 9 | 6.0 ± NA |
| Week 16 | 2.7 ± 1.1 |
Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.
| scores on a scale | Erlotinib Plus Gemcitabine |
|---|---|
| Week 4 | 2.9 ± 1.1 |
| Week 8 | 2.9 ± 1.2 |
| Week 9 | 1.0 ± NA |
| Week 16 | 2.9 ± 1.1 |
Collected over Up to 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib Plus Gemcitabine | — | 171/338 (50.6%) | 261/338 (77.2%) |
| Event | Erlotinib Plus Gemcitabine |
|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 58/338 |
| General physical health deteriorationGeneral disorders | 41/338 |
| CholangitisHepatobiliary disorders | 14/338 |
| InfectionInfections and infestations | 10/338 |
| NauseaGastrointestinal disorders | 9/338 |
| DeathGeneral disorders | 9/338 |
| PainGeneral disorders | 9/338 |
| PyrexiaGeneral disorders | 9/338 |
| PneumoniaInfections and infestations | 9/338 |
| AscitesGastrointestinal disorders | 8/338 |
| Event | Erlotinib Plus Gemcitabine |
|---|---|
| RashSkin and subcutaneous tissue disorders | 172/338 |
| NauseaGastrointestinal disorders | 66/338 |
| PainGeneral disorders | 61/338 |
| FatigueGeneral disorders | 49/338 |
| DiarrhoeaGastrointestinal disorders | 48/338 |
| White blood cell count abnormalInvestigations | 40/338 |
| Platelet count abnormalInvestigations | 38/338 |
| Haemoglobin abnormalInvestigations | 35/338 |
| Oedema peripheralGeneral disorders | 26/338 |
| Decreased appetiteMetabolism and nutrition disorders | 24/338 |
The baseline analysis population included all subjects who received at least one treatment with study medication.
| Age, Continuous(years) | Erlotinib Plus Gemcitabine |
|---|---|
| Mean | 66.9 ± 9.1 |
| Sex: Female, Male(Participants) | Erlotinib Plus Gemcitabine |
|---|---|
| Female | 135 |
| Male | 203 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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