Trial · NCT01782690
An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
NCT01782690, Completed, Hoffmann-La Roche; results first posted 2018-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer. Trials, record NCT01782690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01782690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
- NCT number
- NCT01782690
- Status
- Completed
- Enrollment
- 338 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Cancer
- Interventions
- erlotinib, gemcitabine
- First posted
- 2013-02-04
- Last updated
- 2018-07-23
- Results first posted
- 2018-07-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Stratified by Rash | Up to 12 months | 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. |
| Secondary | Number of Participants With Rash by Severity | Up to 12 months | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 12 months | 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. |
| Secondary | Number of Dose Modifications and Dose Withdrawals of Erlotinib | Up to 12 months | Reported is the total number of dose modifications/withdrawals for erlotinib. |
| Secondary | Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Up to 12 months | Reported is the number of dose modifications/withdrawals for gemcitabine. |
| Secondary | Time of Onset of Rash After Start Erlotinib Treatment | Up to 12 months | Reported is the number of days from first erlotinib treatment to first rash onset. |
| Secondary | Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Up to 12 months | 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. |
| Secondary | Percentage of Participants With Best Overall Response | Up to 12 months | Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. |
| Secondary | Time to Disease Progression | Up to 12 months | Disease progression was defined in accordance with daily routine practice. |
| Secondary | Score in Patient Questionnaire: Possible Side Effects | At Weeks 4, 8, 9 and 16 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Stratified by Rash | Up to 12 months | Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | months | MEDIAN |
| SECONDARY | Number of Participants With Rash by Severity | Up to 12 months | Safety population included all participants who received at least one treatment with study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 12 months | Safety population included all participants who received at least one treatment with study medication. | participants | NUMBER |
| SECONDARY | Number of Dose Modifications and Dose Withdrawals of Erlotinib | Up to 12 months | Safety population included all participants who received at least one treatment with study medication | dose modifications/withdrawals | NUMBER |
| SECONDARY | Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Up to 12 months | Safety population included all participants who received at least one treatment with study medication | dose modifications/withdrawals | NUMBER |
| SECONDARY | Time of Onset of Rash After Start Erlotinib Treatment | Up to 12 months | Safety population included all participants who received at least one treatment with study medication. | days | MEAN |
| SECONDARY | Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Up to 12 months | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response | Up to 12 months | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | percentage of participants | NUMBER |
| SECONDARY | Time to Disease Progression | Up to 12 months | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | months | MEDIAN |
| SECONDARY | Score in Patient Questionnaire: Possible Side Effects | At Weeks 4, 8, 9 and 16 | Safety population included all participants who received at least one treatment with study medication. | scores on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Stratified by Rash | Erlotinib Plus Gemcitabine | Rash = Yes | 9.9288 | 95% Confidence Interval 0.5066 | months |
| Overall Survival Stratified by Rash | Erlotinib Plus Gemcitabine | Rash = No | 8.6795 | 95% Confidence Interval 0.3151 | months |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Total number with rash | 174 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Paronychia Grade 1 | 10 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Paronychia Grade 2 | 7 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Paronychia Grade 3 | 2 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Dry skin Grade 1 | 62 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Dry skin Grade 2 | 26 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Papulopustulous eczema Grade 1 | 89 | participants | |
| Number of Participants With Rash by Severity | Erlotinib Plus Gemcitabine | Papulopustulous eczema Grade 2 | 69 | participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib Plus Gemcitabine | 338 | |
| Overall Study | COMPLETED | Erlotinib Plus Gemcitabine | 39 | |
| Overall Study | NOT COMPLETED | Erlotinib Plus Gemcitabine | 299 |
Source ClinicalTrials.gov
Adverse events175
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Erlotinib Plus Gemcitabine | 19 | 338 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib Plus Gemcitabine | 48 | 338 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib Plus Gemcitabine | 66 | 338 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib Plus Gemcitabine | 20 | 338 | |
| other | Fatigue | General disorders | Erlotinib Plus Gemcitabine | 49 | 338 | |
| other | Oedema peripheral | General disorders | Erlotinib Plus Gemcitabine | 26 | 338 | |
| other | Pain | General disorders | Erlotinib Plus Gemcitabine | 61 | 338 | |
| other | Infection | Infections and infestations | Erlotinib Plus Gemcitabine | 23 | 338 | |
| other | Haemoglobin abnormal | Investigations | Erlotinib Plus Gemcitabine | 35 | 338 | |
| other | Platelet count abnormal | Investigations | Erlotinib Plus Gemcitabine | 38 | 338 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib Plus Gemcitabine | ||
| Total, other adverse events | Erlotinib Plus Gemcitabine | 261 | 338 |
| Total, serious adverse events | Erlotinib Plus Gemcitabine | 171 | 338 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32093649 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01782690
GET https://conductscience.org/api/trials/v1/NCT01782690/results?page=2