Pancreatic CancerPhase 3NCT02694536
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
A Phase 3 study testing Erlotinib and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 11 sites in Italy.
Trial summary
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Erlotinib and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 11 sitesItaly
- Study dates
- 1 Aug 2006to 19 Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
- No prior systemic treatment for metastatic disease
- Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Life expectancy ≥12 weeks
- Adequate hematologic, hepatic, and renal function
- Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential
Who cannot join
- Unstable systemic disease
- Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
- Other malignancy within 5 years prior to study entry
- Significant opthalmologic abnormality
- Inability to take oral medication
- Need for IV alimentation
Show all 9Show fewer
- Prior surgery affecting absorption
- Active peptic ulcer disease
- Nursing mothers
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Study site
Bari, Apulia, 70124
Study site
Bologna, Emilia-Romagna, 40138
Study site
Catania, Sicily, 95126
Study site
Cona (Ferrara), Veneto, 44124
Study site
Naples, Campania, 80131
Study site
Pavia, Lombardy, 27100
Study site
Perugia, Umbria, 06156
Study site
Pisa, Tuscany, 56100
Study site
Pordenone, Friuli Venezia Giulia, 33170
Study site
Rome, Lazio, 00144
Study site
Verona, Veneto, 37126
About this study
Official title: A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Erlotinib, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
GemcitabineDrug
Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib + Gemcitabine | Experimental | Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Receives: Drug: Erlotinib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Measured: Up to approximately 40 months (assessed continuously during treatment)
Secondary outcomes (5)
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available.
Measured: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
Percentage of Participants Who Died
The percentage of participants who died from any cause was reported to the nearest integer.
Measured: Up to approximately 40 months (assessed continuously through end of study)
Overall Survival (OS)
OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.
Measured: Up to approximately 40 months (assessed continuously through end of study)
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.
Measured: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Progression-Free Survival (PFS) According to RECIST
Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.
Measured: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start1 Aug 2006
- Primary completion19 Nov 2009
- Study completion19 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694536
- Sponsor's protocol ID
- ML19537
- Other IDs
- 2005-004605-29, 2005
- Status last verified
- Feb 2017
- First submitted
- 24 Feb 2016
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02694536
- Acronym / sponsor ID
- ML19537
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2006
- Primary completion
- 19 Nov 2009 (actual)
- Study completion
- 19 Nov 2009 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib + Gemcitabine | Experimental | Drug: Erlotinib, Drug: GemcitabineParticipants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
- No prior systemic treatment for metastatic disease
- Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Life expectancy ≥12 weeks
Key exclusion criteria (9 listed)
- Unstable systemic disease
- Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
- Other malignancy within 5 years prior to study entry
- Significant opthalmologic abnormality
- Inability to take oral medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: TarcevaParticipants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily. | Drug | Erlotinib + Gemcitabine |
| GemcitabineParticipants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle. | Drug | Erlotinib + Gemcitabine |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 40 months (assessed continuously during treatment)
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
5 secondary outcomes
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Time frame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
Percentage of Participants Who Died
Time frame: Up to approximately 40 months (assessed continuously through end of study)
Overall Survival (OS)
Time frame: Up to approximately 40 months (assessed continuously through end of study)
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Progression-Free Survival (PFS) According to RECIST
Time frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 40 months (assessed continuously during treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.