Pancreatic CancerPhase 2PACT-9NCT00966706
Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer
A Phase 2 study testing capecitabine, cisplatin and docetaxel in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2005to Oct 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas
- Stage III or IV disease
- Measurable disease
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Adequate bone marrow, liver, and kidney function
- Not pregnant or nursing
- No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin
- No multiple severe diseases that can compromise study safety, including any of the following:
- Cardiac failure
- Myocardial infarction within the past 4 months
- Cardiac arrhythmia
- History of psychiatric disabilities
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for pancreatic cancer
- No other concurrent experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, 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. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
- Evaluate the activity and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients may then undergo surgery if the tumor becomes resectable.
- Conditions
- Pancreatic Cancer
- Being tested
- capecitabine, cisplatin, docetaxel, epirubicin hydrochloride, gemcitabine hydrochloride
- Keywords
- adenocarcinoma of the pancreas, stage III pancreatic cancer, 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
Given systemically
cisplatinDrug
Also called Cisplatino-TEVA
Given systemically
docetaxelDrug
Also called TAXOTERE
Given systemically
epirubicin hydrochlorideDrug
Also called FARMARUBICINA
Given systemically
Also called GEMZAR
Given systemically
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: capecitabine; Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride |
| Arm II | Experimental | Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: gemcitabine hydrochloride |
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 during therapy; every 3 months thereafter
Secondary outcomes (3)
Overall survival
Measured: monthly
Response rate
CT scan
Measured: every 2 months during therapy; every 3 months thereafter
Toxicity
outpatient visit
Measured: every 2 weeks during therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJun 2005
- Primary completionApr 2009
- Study completionOct 2009
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
- 105 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
- NCT00966706
- Sponsor's protocol ID
- CDR0000642240
- Other IDs
- SRSI-PACT-9, 2005-002586-36, 2005
- Acronym
- PACT-9
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT00966706
- Acronym / sponsor ID
- PACT-9 / CDR0000642240
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Aug 2009 (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, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, 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. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.
Detailed description
OBJECTIVES:
- Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
- Evaluate the activity and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients may then undergo surgery if the tumor becomes resectable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: capecitabine, Drug: cisplatin, Drug: docetaxel, Drug: gemcitabine hydrochloridePatients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: capecitabine, Drug: cisplatin, Drug: epirubicin hydrochloride, Drug: gemcitabine hydrochloridePatients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
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: XELODAGiven systemically | Drug | Arm I, Arm II |
| cisplatinAlso: Cisplatino-TEVAGiven systemically | Drug | Arm I, Arm II |
| docetaxelAlso: TAXOTEREGiven systemically | Drug | Arm I |
| epirubicin hydrochlorideAlso: FARMARUBICINAGiven systemically | Drug | Arm II |
| gemcitabine hydrochlorideAlso: GEMZARGiven systemically | Drug | Arm I, Arm II |
Primary outcome
Progression-free survival at 6-months
Time frame: every 2 months during therapy; every 3 months thereafter
CT scan
3 secondary outcomes
Overall survival
Time frame: monthly
Response rate
Time frame: every 2 months during therapy; every 3 months thereafter
Toxicity
Time frame: every 2 weeks during therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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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.
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 docetaxel 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: finished, as of the sponsor's last update on 1 Feb 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 during therapy; every 3 months thereafter). 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 1 Feb 2012.