Pancreatic CancerPhase 2PACT-17NCT01167738
Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing capecitabine, cisplatin and epirubicin in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- capecitabine, cisplatin and epirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Apr 2015
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Metastatic (stage IV) disease
- Measurable disease
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- Adequate bone marrow, liver and kidney function
- No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
- No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
- No alcohol abuse
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or metformin
- No other concurrent experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.
Secondary
- To assess the overall survival of patients treated with this regimen.
- To assess the response rate in patients treated with this regimen.
- To assess the duration of response in patients treated with this regimen.
- To assess the toxicity in patients treated with this regimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Conditions
- Pancreatic Cancer
- Being tested
- capecitabine, cisplatin, epirubicin, gemcitabine, metformin
- Keywords
- adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called XELODA
1250 mg/mq days 1-28 every 4 weeks
cisplatinDrug
Also called cisplatino TEVA
30 mg/mq on days 1 and 15 every 4 weeks
epirubicinDrug
Also called farmorubicina
30 mg/mq on days 1 and 15 every 4 weeks
gemcitabineDrug
Also called GEMZAR
800 mg/mq on days 1 and 15 every 4 weeks
metforminDrug
Also called glucophage
2 g days 1-28 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEXG regimen + metformin | Experimental | cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28 Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: gemcitabine; Drug: metformin |
| PEXG regimen | Active comparator | cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15 Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 6 months
CT scan
Measured: every 2 months
Secondary outcomes (3)
Overall survival
outpatient visit, phone interview
Measured: every 14 days during therapy; every 3 months thereafter
Response rate
CT scan
Measured: every 2 months
Toxicity
outpatient visit, laboratory findings
Measured: every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionApr 2015
Why it stopped: concern of detrimental effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Reni, IRCCS San Raffaele
- Investigators
- Michele Reni, MD, Principal investigator, Istituto Scientifico H. San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167738
- Sponsor's protocol ID
- CDR0000681691
- Other IDs
- PACT-17, 2010-020979-23
- Acronym
- PACT-17
- Status last verified
- Apr 2015
- First submitted
- 21 Jul 2010
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01167738
- Acronym / sponsor ID
- PACT-17 / CDR0000681691
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: concern of detrimental effect
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Jul 2010 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.
Secondary
- To assess the overall survival of patients treated with this regimen.
- To assess the response rate in patients treated with this regimen.
- To assess the duration of response in patients treated with this regimen.
- To assess the toxicity in patients treated with this regimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEXG regimen + metformin | Experimental | Drug: capecitabine, Drug: cisplatin, Drug: epirubicin, Drug: gemcitabine, Drug: metformincisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28 |
| PEXG regimen | Active comparator | Drug: capecitabine, Drug: cisplatin, Drug: epirubicin, Drug: gemcitabinecisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabineAlso: XELODA1250 mg/mq days 1-28 every 4 weeks | Drug | PEXG regimen, PEXG regimen + metformin |
| cisplatinAlso: cisplatino TEVA30 mg/mq on days 1 and 15 every 4 weeks | Drug | PEXG regimen, PEXG regimen + metformin |
| epirubicinAlso: farmorubicina30 mg/mq on days 1 and 15 every 4 weeks | Drug | PEXG regimen, PEXG regimen + metformin |
| gemcitabineAlso: GEMZAR800 mg/mq on days 1 and 15 every 4 weeks | Drug | PEXG regimen, PEXG regimen + metformin |
| metforminAlso: glucophage2 g days 1-28 every 4 weeks | Drug | PEXG regimen + metformin |
Primary outcome
Progression-free survival at 6 months
Time frame: every 2 months
CT scan
3 secondary outcomes
Overall survival
Time frame: every 14 days during therapy; every 3 months thereafter
Response rate
Time frame: every 2 months
Toxicity
Time frame: every 2 weeks
Results and safety
The study was stopped early (reason given: concern of detrimental effect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Michele Reni, MD principal investigator
Istituto Scientifico H. San Raffaele
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 capecitabine, cisplatin and epirubicin in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Apr 2015. 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 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?
The study was stopped early (reason given: concern of detrimental effect). 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?
Progression-free survival at 6 months (time frame: every 2 months). 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 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.