Metastatic Pancreatic AdenocarcinomaPhase 2ML22774NCT01729481
Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Erlotinib and Oxaliplatin in people with Metastatic Pancreatic Adenocarcinoma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
In the current study it is examined whether patients with good risk factors (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine, Erlotinib and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically (not cytologically) confirmed metastatic pancreatic adenocarcinoma (stage IV according to UICC, each T, each N, M1 according to TNM)
- At least one measurable index lesion (CT or MRI) according to RECIST criteria (V 1.1)
- ECOG PS 0 and 1
- Age 18-75 years
- Serum bilirubin ≤1,5x ULN (a placed biliary tract stent without concurrent cholangitis is not considered a contraindication)
- Availability of tumour samples (no cytologic samples)
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- Written informed consent by the patient for collecting blood- and tumour-samples for translational research according to study protocol
- Live expectancy of at least three months
- Written informed consent
- Negative pregnancy test in women with childbearing potential (to be performed within 7 days prior to treatment start)
- Adequate kidney-, liver- and bone-marrow function: neutrophils >= 1500/µl, platelets >= 100.000/µ, and hemoglobin >= 8g/dl, liver transaminases<= 2,5x ULN, in case of liver metastases <= 5x ULN, serum creatinine <= 1,25x ULN, creatinine clearance ≥ 30 ml/min
- Legal capacity of the patient
- Option for constant long-term follow-up
Who cannot join
- Resectable pancreatic carcinoma
- Locally advanced pancreatic cancer (non-resectable tumour without distant metastasis)
- Previous palliative chemotherapy for metastatic or locally advanced, non-resectable pancreatic cancer
- Previous palliative radiation or chemoradiation for locally advanced, non-resectable pancreatic cancer
- Radiation therapy within four weeks prior to study enrolment or radiation of indicator lesions
- Adjuvant Chemotherapy or Radiochemotherapy for pancreatic cancer ≤ 6 months prior to study ernrolment
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- All previously occurred metastatic cancers or cured neoplasias diagnosed within the last 5 years before study enrolment
- Major surgery within 2 weeks before study start
- Chronic diarrhea
- Known glucuronidation-deficiency (Gilbert´s syndrome)
- Acute or subacute ileus or chronic inflammatory bowel disease
- Preexisting polyneuropathy > Grade I according to NCI-CTCAE v.4.0
- Relevant comorbidities which might impair patient eligibility or safety for study participation like active infections, hepatic, renal or metabolic diseases
- Clinically significant cardiovascular diseases within 12 months prior to study start (e.g. unstable angina pectoris, myocardial infarction, heart failure ≥ NYHA II, cardiac arrhythmias requiring treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances
In the current study it is examined whether patients with good risk factors (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.
Read the detailed description
The study by Burris et al. 1997 revealed a superiority of gemcitabine vs. 5-FU in terms of improvement of general condition, pain symptoms and overall survival in patients with locally advanced or metastatic pancreatic cancer. Subsequently, gemcitabine was established as a standard treatment for locally advanced and metastatic pancreatic cancer.
In a series of studies gemcitabine was combined with other chemotherapeutic agents or targeted therapies. For the first time, the PA.03 study showed a significant improvement of overall survival. Patients who were treated with gemcitabine plus erlotinib had a survival of 6.24 months, compared with 5.91 months for those treated with gemcitabine plus placebo (HR 0.82, 95% CI 0.69-0.99, p=0.038). The one-year-survival rate was 23% for gemcitabine plus erlotinib vs. 17% for gemcitabine plus placebo.
In a subgroup analysis of the PA.03 study, patients developing a skin rash NCI CTC ≥ grade 2 had an advanced survival (one-year-survival rate 43%) vs. those with grade 1 or 0 (one-year-survival rate 16% and 9%, respectively). Later studies confirmed the correlation between skin rash and survival.
While patients developing a skin rash of any grade seem to profit most from treatment with erlotinib, the prognosis for those without rash is rather dismal. In this population, survival varied between 3.3 and 4.8 months in clinical trials (Verslype et al. 2009, Boeck et al. 2010, Manzano et al. 2010). In this patients, a modification of the treatment strategy should be considered. Which kind of treatment might lead to optimal results in these patients is not yet clear.
In patients with excellent general condition complying with further prerequisits (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) the French Prodige study-group could show a statistical superiority for the gemcitabine-free FOLFIRINOX-scheme in terms of overall survival, progression free survival and response rate compared to gemcitabine alone. However, this superiority was gained at the expense of treatment tolerability. During treatment with FOLFIRINOX a grade 3-4 neutropenia was observed in 5.4% and a grade 3-4 diarrhea in 12.7% of patients (Conroy et al. 2011). For patients who comply with the above-named criteria FOLFIRINOX is considered an established standard of care.
If a comparable efficacy of gemcitabine plus erlotinib with the published FOLFIRINOX data can be seen in the selected population, this would favour, due to the worse tolerability of FOLFIRINOX, the use of gemcitabine plus erlotinib.
In summary, the following selections are conducted during the study:
- Selection due to the inclusion criteria for treatment with FOLFIRINOX provided by Conroy et al.
- Selection due to the development of a skin rash within four weeks of treatment
- No signs of clinical tumour progression within the run-in phase within the first four weeks of treatment
Patients who do not develope a skin rash of any grade should be treated with FOLFIRINOX. The efficacy of FOLFIRINOX in rash-negative patients has not yet been investigated.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, Erlotinib, Oxaliplatin, Folinic Acid, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1000 mg/m² iv weekly
ErlotinibDrug
Also called Tarceva
100mg, once per day
OxaliplatinDrug
Also called Eloxatin
85mg/m², q2weeks
Folinic AcidDrug
Also called Leucovorin
400 mg/m², q2weeks
IrinotecanDrug
Also called Campto
180 mg/m², q2weeks
5-FUDrug
Also called 5-Flourouracil
400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks
| Study group | Role | What they receive |
|---|---|---|
| RASH positive | Experimental | Run-In-Phase during 4 weeks:
Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly
Thereafter Treatment in patients with RASH-positve outcome after 4 weeks. Receives: Drug: Gemcitabine; Drug: Erlotinib |
| RASH-negative | Active comparator | Run-In-Phase during 4 weeks:
Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly
RASH-negative patients quit treatment with Gemcitabine + Erlotinib and continue treatment with FOLFIRINOX:
Oxaliplatin 85mg/m2 Irinotecan 180 mg/m2 Folinic acid 400 mg/m2 5-FU 400 mg/m2 bolus iv 5-FU 2400 mg/m2 46-hours continous infusion Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Irinotecan; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Survial rate of "good-risk" patients
1-year Survial rate of "good-risk" patients of patients under gemcitabine plus erlotinib with RASH
Measured: Follow-Up Phase (1.5 years)
Secondary outcomes (3)
Evalutation of overall response rate, disease control rate and progression free survival
Evaluation of Parameters by RASH positve and negative patients:
- ORR
- DCR
- PFS
- OS
Measured: Approximately 12 months
Evaluation of adverse events
Assesment with NCI-CTCAE V4.0 Evalutation of side effects including picture documentation of skin-rash
Measured: Treatment Phase (1.5 Years)
Translational Projects
- Evaluation of Parameters for EGFR signal transduction
- Evaluation Molecularbiological Parametrs of RASH
- Picture Documentation of RASH. Corellation with clinical and molecularbiological Parameters
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Volker Heinemann, Professor, Principal investigator, Medical Department III and Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729481
- Sponsor's protocol ID
- 2011-005471-17
- Acronym
- ML22774
- Status last verified
- Jul 2017
- First submitted
- 23 Oct 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.
PubMed 37794220Haas M, Siveke JT, Schenk M, Lerch MM, Caca K, Freiberg-Richter J, Fischer von Weikersthal L, Kullmann F, Reinacher-Schick A, Fuchs M, Kanzler S, Kunzmann V, Ettrich TJ, Kruger S, Westphalen CB, Held S, Heinemann V, Boeck S. Efficacy of gemcitabine plus erlotinib in rash-positive patients with metastatic pancreatic cancer selected according to eligibility for FOLFIRINOX: A prospective phase II study of the 'Arbeitsgemeinschaft Internistische Onkologie'. Eur J Cancer. 2018 May;94:95-103. doi: 10.1016/j.ejca.2018.02.008. Epub 2018 Mar 20.
PubMed 29549862
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances
- ClinicalTrials.gov ID
- NCT01729481
- Acronym / sponsor ID
- ML22774 / 2011-005471-17
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current study it is examined whether patients with good risk factors (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.
Detailed description
The study by Burris et al. 1997 revealed a superiority of gemcitabine vs. 5-FU in terms of improvement of general condition, pain symptoms and overall survival in patients with locally advanced or metastatic pancreatic cancer. Subsequently, gemcitabine was established as a standard treatment for locally advanced and metastatic pancreatic cancer.
In a series of studies gemcitabine was combined with other chemotherapeutic agents or targeted therapies. For the first time, the PA.03 study showed a significant improvement of overall survival. Patients who were treated with gemcitabine plus erlotinib had a survival of 6.24 months, compared with 5.91 months for those treated with gemcitabine plus placebo (HR 0.82, 95% CI 0.69-0.99, p=0.038). The one-year-survival rate was 23% for gemcitabine plus erlotinib vs. 17% for gemcitabine plus placebo.
In a subgroup analysis of the PA.03 study, patients developing a skin rash NCI CTC ≥ grade 2 had an advanced survival (one-year-survival rate 43%) vs. those with grade 1 or 0 (one-year-survival rate 16% and 9%, respectively). Later studies confirmed the correlation between skin rash and survival.
While patients developing a skin rash of any grade seem to profit most from treatment with erlotinib, the prognosis for those without rash is rather dismal. In this population, survival varied between 3.3 and 4.8 months in clinical trials (Verslype et al. 2009, Boeck et al. 2010, Manzano et al. 2010). In this patients, a modification of the treatment strategy should be considered. Which kind of treatment might lead to optimal results in these patients is not yet clear.
In patients with excellent general condition complying with further prerequisits (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) the French Prodige study-group could show a statistical superiority for the gemcitabine-free FOLFIRINOX-scheme in terms of overall survival, progression free survival and response rate compared to gemcitabine alone. However, this superiority was gained at the expense of treatment tolerability. During treatment with FOLFIRINOX a grade 3-4 neutropenia was observed in 5.4% and a grade 3-4 diarrhea in 12.7% of patients (Conroy et al. 2011). For patients who comply with the above-named criteria FOLFIRINOX is considered an established standard of care.
If a comparable efficacy of gemcitabine plus erlotinib with the published FOLFIRINOX data can be seen in the selected population, this would favour, due to the worse tolerability of FOLFIRINOX, the use of gemcitabine plus erlotinib.
In summary, the following selections are conducted during the study:
- Selection due to the inclusion criteria for treatment with FOLFIRINOX provided by Conroy et al.
- Selection due to the development of a skin rash within four weeks of treatment
- No signs of clinical tumour progression within the run-in phase within the first four weeks of treatment
Patients who do not develope a skin rash of any grade should be treated with FOLFIRINOX. The efficacy of FOLFIRINOX in rash-negative patients has not yet been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RASH positive | Experimental | Drug: Gemcitabine, Drug: ErlotinibRun-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly Thereafter Treatment in patients with RASH-positve outcome after 4 weeks. |
| RASH-negative | Active comparator | Drug: Oxaliplatin, Drug: Folinic Acid, Drug: Irinotecan, Drug: 5-FURun-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly RASH-negative patients quit treatment with Gemcitabine + Erlotinib and continue treatment with FOLFIRINOX: Oxaliplatin 85mg/m2 Irinotecan 180 mg/m2 Folinic acid 400 mg/m2 5-FU 400 mg/m2 bolus iv 5-FU 2400 mg/m2 46-hours continous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically (not cytologically) confirmed metastatic pancreatic adenocarcinoma (stage IV according to UICC, each T, each N, M1 according to TNM)
- At least one measurable index lesion (CT or MRI) according to RECIST criteria (V 1.1)
- ECOG PS 0 and 1
- Age 18-75 years
- Serum bilirubin ≤1,5x ULN (a placed biliary tract stent without concurrent cholangitis is not considered a contraindication)
Key exclusion criteria (14 listed)
- Resectable pancreatic carcinoma
- Locally advanced pancreatic cancer (non-resectable tumour without distant metastasis)
- Previous palliative chemotherapy for metastatic or locally advanced, non-resectable pancreatic cancer
- Previous palliative radiation or chemoradiation for locally advanced, non-resectable pancreatic cancer
- Radiation therapy within four weeks prior to study enrolment or radiation of indicator lesions
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 |
|---|---|---|
| GemcitabineAlso: Gemzar1000 mg/m² iv weekly | Drug | RASH positive |
| ErlotinibAlso: Tarceva100mg, once per day | Drug | RASH positive |
| OxaliplatinAlso: Eloxatin85mg/m², q2weeks | Drug | RASH-negative |
| Folinic AcidAlso: Leucovorin400 mg/m², q2weeks | Drug | RASH-negative |
| IrinotecanAlso: Campto180 mg/m², q2weeks | Drug | RASH-negative |
| 5-FUAlso: 5-Flourouracil400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks | Drug | RASH-negative |
Primary outcome
1-year Survial rate of "good-risk" patients
Time frame: Follow-Up Phase (1.5 years)
1-year Survial rate of "good-risk" patients of patients under gemcitabine plus erlotinib with RASH
3 secondary outcomes
Evalutation of overall response rate, disease control rate and progression free survival
Time frame: Approximately 12 months
Evaluation of adverse events
Time frame: Treatment Phase (1.5 Years)
Translational Projects
Time frame: Approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 37794220Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.
- Derived from this study: PubMed 29549862Haas M, Siveke JT, Schenk M, Lerch MM, Caca K, Freiberg-Richter J, Fischer von Weikersthal L, Kullmann F, Reinacher-Schick A, Fuchs M, Kanzler S, Kunzmann V, Ettrich TJ, Kruger S, Westphalen CB, Held S, Heinemann V, Boeck S. Efficacy of gemcitabine plus erlotinib in rash-positive patients with metastatic pancreatic cancer selected according to eligibility for FOLFIRINOX: A prospective phase II study of the 'Arbeitsgemeinschaft Internistische Onkologie'. Eur J Cancer. 2018 May;94:95-103. doi: 10.1016/j.ejca.2018.02.008. Epub 2018 Mar 20.
- Homepage of the PancreasCenter at LMU MunichLink provided by the sponsor.
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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.
Volker Heinemann, Professor principal investigator
Medical Department III and Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Erlotinib and Oxaliplatin in people with Metastatic Pancreatic Adenocarcinoma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
1-year Survial rate of "good-risk" patients (time frame: Follow-Up Phase (1.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729481, which also lists 2 linked publications.
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 19 Jul 2017.