Locally Advanced Pancreatic CancerPhase 2MAPSNCT00758381
Metastatic Advanced Pancreas Sorafenib
A Phase 2 study testing Sorafenib 400 mg po bid, continuously and Gemcitabina, Cisplatino in people with Locally Advanced Pancreatic Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 17 sites in Italy.
Trial summary
This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Sorafenib 400 mg po bid, continuously and Gemcitabina, Cisplatino
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 17 sitesItaly
- Study dates
- Aug 2007to Aug 2009
- 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
- Signed written informed consent prior to beginning protocol specific procedures
- Male or female 18 to 75 years of age
- Diagnosis of histologically confirmed adenocarcinoma of the pancreas
- Locally advanced (non-resectable) or metastatic pancreatic cancer
- Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
- Karnofsky performance status of ≥ 70 at study entry
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- Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
- Bilirubin level either normal or < 1.5 x ULN
- ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
- Serum creatinine < 1.5 x ULN
- Amylase and lipase ≤ 1.5 x the upper limit of normal
- PT or INR and PTT < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists).
- Effective contraception for both male and female patients if the risk of conception exists
Who cannot join
- Brain metastases
- Previous chemotherapy for locally advanced or metastatic pancreatic cancer.
- Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)
- Radiotherapy within 4 weeks prior to study entry
- Major surgery within 4 weeks of first dose of study drug
- Concurrent chronic systemic immune therapy
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- Any investigational agent(s) 4 weeks prior to entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- Known grade 3 or 4 allergic reaction to any of the components of the treatment
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Women who are pregnant or breastfeeding
- Acute or subacute intestinal occlusion
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites, 11 recruiting
- Recruiting
A.O. Universitaria Ospedali Riuniti Umberto I
Ancona, Ancona, 60020
Stefano Cascinu, M.Pr
- Recruiting
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, 24128
Roberto Labianca, MD
- Active, not recruiting
A.O.Policlinico S.Orsola Malpighi
Bologna, Bologna, 40138
- Active, not recruiting
Ospedale S.Orsola Fatebenefratelli
Brescia, BS, 15100
- Recruiting
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, 50139
Francesco Di Costanzo, MD
- Active, not recruiting
Ospedale Galliera
Genova, Genova, 16132
- Recruiting
A.O. Ospedale S.Martino
Genova, GE, 16132
Alberto Sobrero, MD
- Recruiting
A.O. Carlo Poma - Via Albertoni, 1
Mantua, Mantova, 46100
Enrico Aitini, MD
- Recruiting
A.O. Cà Granda, Piazza Ospedale Maggiore, 3
Milan, Milano, 20162
Salvatore Siena, MPr
- Recruiting
A.O. san Paolo
Milan, MI, 20100
Paolo Foa, MD
- Not yet recruiting
Casa di Cura Igea
Milan, MI, 20100
Gianfranco Pancera, MD
- Not yet recruiting
Ospedale S.Carlo Borromeo
Milan, MI, 20123
Donata Tabiadon, MD
- Active, not recruiting
Policlinico di modena
Modena, Modena, 41100
- Recruiting
A.O. S.Gerardo
Monza, MI, 20052
Paolo Bidoli, MD
- Active, not recruiting
Università Campus Biomedico, Via Emilio Longoni, 83
Roma, Roma, 00155
- Active, not recruiting
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, Roma, 00186
- Recruiting
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, 24047
sandro Barni, MD
About this study
Official title: A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial
This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.
Read the detailed description
Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine is commonly used in patients with pancreatic cancer with the purpose of symptom palliation, there is no clear evidence of efficacy in terms of survival increase or progression control. Furthermore, attempts at improving results by combining gemcitabine with other cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib) showed a small survival advantage when combined with gemcitabine. results obtained with a combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a statistical significant survival advantage for the combination.
Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able to inhibit both VEGFR and PDGFR.
Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful in the management of these tumours. Furthermore, it may be combined with gemcitabine and cisplatin without any pharmacokinetic interaction or enhanced toxicity.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Sorafenib 400 mg po bid, continuously, Gemcitabina, Cisplatino
- Keywords
- pancreatic cancer, advanced or metastatic, sorafenib
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib 400 mg po bid, continuouslyDrug
Also called L01XE05 V, Sostanza attiva o descrizione del livello ATC selezionato, SORAFENIB TOSILATO
NEXAVAR*112CPR RIV 200MG
Titolare AIC:
BAYER SpA
Numero di AIC dell'IMP:
037154010
Gemcitabina, CisplatinoDrug
Also called GEMZAR*INFUS 1FL 1G POLV, Titolare AIC:, ELI LILLY ITALIA SpA, Numero di AIC dell'IMP:
Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sorafenib 400 mg po bid, continuously
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days. Receives: Drug: Sorafenib 400 mg po bid, continuously |
| B | Active comparator | Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days Receives: Drug: Gemcitabina, Cisplatino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: time from randomization date to date of local or regional relapse
Secondary outcomes (1)
- overall Response Rate (RECIST Criteria) - duration of response - overall survival time
Measured: time from the day of randomization to the date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2008 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Investigators
- Stefano Cascinu, M.Professor, Study chair, GISCAD Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758381
- Sponsor's protocol ID
- 2007-001781-32
- Acronym
- MAPS
- Status last verified
- Oct 2008
- First submitted
- 22 Sep 2008
- Last updated
- 10 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial
- ClinicalTrials.gov ID
- NCT00758381
- Acronym / sponsor ID
- MAPS / 2007-001781-32
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- pancreatic cancer, advanced or metastatic, sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Gruppo Italiano per lo studio dei Carcinomi dell'Apparato DigerenteUniversity, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 25 Sep 2008 (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.
This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.
Detailed description
Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine is commonly used in patients with pancreatic cancer with the purpose of symptom palliation, there is no clear evidence of efficacy in terms of survival increase or progression control. Furthermore, attempts at improving results by combining gemcitabine with other cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib) showed a small survival advantage when combined with gemcitabine. results obtained with a combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a statistical significant survival advantage for the combination.
Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able to inhibit both VEGFR and PDGFR.
Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful in the management of these tumours. Furthermore, it may be combined with gemcitabine and cisplatin without any pharmacokinetic interaction or enhanced toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sorafenib 400 mg po bid, continuouslySorafenib 400 mg po bid, continuously Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days. |
| B | Active comparator | Drug: Gemcitabina, CisplatinoGemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent prior to beginning protocol specific procedures
- Male or female 18 to 75 years of age
- Diagnosis of histologically confirmed adenocarcinoma of the pancreas
- Locally advanced (non-resectable) or metastatic pancreatic cancer
- Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
Key exclusion criteria (17 listed)
- Brain metastases
- Previous chemotherapy for locally advanced or metastatic pancreatic cancer.
- Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)
- Radiotherapy within 4 weeks prior to study entry
- Major surgery within 4 weeks of first dose of study drug
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 |
|---|---|---|
| Sorafenib 400 mg po bid, continuouslyAlso: L01XE05 V, Sostanza attiva o descrizione del livello ATC selezionato, SORAFENIB TOSILATONEXAVAR*112CPR RIV 200MG Titolare AIC: BAYER SpA Numero di AIC dell'IMP: 037154010 | Drug | A |
| Gemcitabina, CisplatinoAlso: GEMZAR*INFUS 1FL 1G POLV, Titolare AIC:, ELI LILLY ITALIA SpA, Numero di AIC dell'IMP:Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days | Drug | B |
Primary outcome
Progression Free Survival
Time frame: time from randomization date to date of local or regional relapse
1 secondary outcome
- overall Response Rate (RECIST Criteria) - duration of response - overall survival time
Time frame: time from the day of randomization to the date of death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2008.
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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.
Stefano Cascinu, M.Professor study chair
GISCAD Foundation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib 400 mg po bid, continuously and Gemcitabina, Cisplatino in people with Locally Advanced Pancreatic Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 17 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 13 inclusion and 17 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 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
Contact Stefano Cascinu, MProfessor (+39 071 5964 ext. 171, cascinu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: time from randomization date to date of local or regional relapse). 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 10 Oct 2008.