Pancreatic CancerPhase 2PACT-12NCT00967603
Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer
A Phase 2 study testing sunitinib in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are… 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?
- sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologically confirmed metastatic pancreatic adenocarcinoma
- Stage IV disease
- Received chemotherapy for a duration of 6 months
- No progressive disease for ≥ 6 months since beginning of induction chemotherapy (irrespective of regimen and response: stable disease, partial response, or complete response) demonstrated by the following:
- Two consecutive CT or MR scans separated by ≥ 6 weeks
- Normal or no CA19.9 increase > 20% during the last month
PATIENT CHARACTERISTICS:
- Karnofsky Performance Status 50-100%
- Adequate bone marrow, liver, and kidney function
- Normal thyroid gland function (euthyroid)
- Not pregnant or nursing
- No duodenal, gastric, or intestinal infiltration
- Able to take oral medication
- None of the following conditions related to cardiac disease, failure, or vascular disease including any of the following:
- QTc interval prolongation
- Congestive heart failure
- Serious cardiac arrhythmias
- Active coronary artery disease
- Myocardial infarction
- Ischemia
- Cerebrovascular accident
- Evidence of pre-existing uncontrolled hypertension
- No other malignancies except surgically cured carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or other adequately treated neoplasms for which the patient has been disease-free for ≥ 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other prior chemotherapy apart from first-line treatment for pancreatic cancer
- More than 3 weeks and less than 8 weeks since prior chemotherapy (> 1 week in the case of fluorouracil as continuous infusion or capecitabine)
- No prior antiangiogenesis drugs, including any of the following:
- Sunitinib malate
- Sorafenib
- Bevacizumab
- AZD2171
- Vatalanib
- VEGF trap
- Pazopanib
- More than 1 month since prior major surgical procedure and completely recovered
- More than 7-12 days since prior and no concurrent drugs that are known CYP3A4 inhibitors
- No concurrent drugs with potential anti-arrhythmic activity
- No concurrent thrombolytic agent at therapeutical dose
- No concurrent treatment with other experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy.
PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic cancer without progression after 6 months of induction chemotherapy treated with sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
- Conditions
- Pancreatic Cancer
- Being tested
- sunitinib
- 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.
sunitinibDrug
Also called SUTENT
oral sunitinib 37.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| observation | No intervention | no therapy until progression |
| sunitinib | Experimental | sunitinib until progression or for a maximum of 6 months Receives: Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival
CT scan
Measured: every 2 months during therapy; every 3 months thereafter
Secondary outcomes (8)
Response rate
CT scan
Measured: every 2 months during therapy; every 3 months thereafter
Toxicity
outpatient visit
Measured: monthly during therapy
OVERALL SURVIVAL
outpatient visit
Measured: monthly
PROGRESSION-FREE SURVIVAL
CT scan
Measured: every 2 months during therapy; every 3 months thereafter
endothelial circulating cells
Measured: baseline + every 2 months during therapy until progression
pharmacogenomics
Measured: baseline
pharmacokynetics
Measured: after 2 months of therapy
pharmacodynamics
Measured: baseline and every 2 months until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionJan 2012
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
- 56 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
- NCT00967603
- Sponsor's protocol ID
- CDR0000643632
- Other IDs
- PACT-12, 2008-000814-65, 2008
- Acronym
- PACT-12
- Status last verified
- Dec 2009
- First submitted
- 27 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
- Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
- ClinicalTrials.gov ID
- NCT00967603
- Acronym / sponsor ID
- PACT-12 / CDR0000643632
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 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: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy.
PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic cancer without progression after 6 months of induction chemotherapy treated with sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | No intervention | –no therapy until progression |
| sunitinib | Experimental | Drug: sunitinibsunitinib until progression or for a maximum of 6 months |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| sunitinibAlso: SUTENToral sunitinib 37.5 mg daily | Drug | sunitinib |
Primary outcome
6-month progression-free survival
Time frame: every 2 months during therapy; every 3 months thereafter
CT scan
8 secondary outcomes
Response rate
Time frame: every 2 months during therapy; every 3 months thereafter
Toxicity
Time frame: monthly during therapy
OVERALL SURVIVAL
Time frame: monthly
PROGRESSION-FREE SURVIVAL
Time frame: every 2 months during therapy; every 3 months thereafter
endothelial circulating cells
Time frame: baseline + every 2 months during therapy until progression
pharmacogenomics
Time frame: baseline
pharmacokynetics
Time frame: after 2 months of therapy
pharmacodynamics
Time frame: baseline and every 2 months until progression
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 sunitinib 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?
6-month progression-free survival (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.