Pancreatic CancerPhase 2PACT-18NCT01339754
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
A Phase 2 study testing trabectedin in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as trabectedin, 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?
- trabectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Mar 2013
- 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 confirmed adenocarcinoma of the pancreas
- Metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy
- May be given with neoadjuvant, adjuvant, or palliative therapy
- Measurable disease according to RECIST criteria
- No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Bone marrow, liver, and kidney function normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe comorbidities, including any of the following:
- Cardiac disease
- History of psychiatric disability
- No other prior or concurrent malignancy except surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, and other neoplasms without evidence of disease for ≥ 5 years
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior second-line chemotherapy
- No other concurrent chemotherapy or target therapy
- No concurrent treatment with other experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy.
Secondary
- To assess the safety profile of this drug.
- To assess the response rate and response duration.
- To assess the overall survival of these patients.
- To assess the PFS rate at 9 and 18 weeks.
- To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies.
OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Pancreatic Cancer
- Being tested
- trabectedin
- Keywords
- recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
Also called YONDELIS
1.3 mg/mq as a 3 hour continuous infusion every three weeks
trabectedinDrug
Also called ET 743
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
| Study group | Role | What they receive |
|---|---|---|
| trabectedin | Experimental | 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression Receives: Drug: trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate at 6 months
CT scan
Measured: every 9 weeks
Secondary outcomes (6)
Safety profile
outpatient visit, laboratory findings
Measured: every 3 weeks
Response rate and response duration
CT scan
Measured: every 2 months
Overall survival
outpatient visit, phone interview
Measured: every 3 weeks during therapy, every 2-3 months thereafter
PFS rate at 9 and 18 weeks
CT scan
Measured: every 9 weeks
Identify biomarkers predictive for resistance or sensitivity to trabectedin
tissue, blood, serum collection
Measured: at trial start
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity
blood samples
Measured: based on a pre-definid sample collection schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionMar 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01339754
- Sponsor's protocol ID
- CDR0000698981
- Other IDs
- PACT-18, 2010-024287-17
- Acronym
- PACT-18
- Status last verified
- Aug 2014
- First submitted
- 20 Apr 2011
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT01339754
- Acronym / sponsor ID
- PACT-18 / CDR0000698981
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Apr 2011 (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 trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy.
Secondary
- To assess the safety profile of this drug.
- To assess the response rate and response duration.
- To assess the overall survival of these patients.
- To assess the PFS rate at 9 and 18 weeks.
- To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies.
OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trabectedin | Experimental | Drug: trabectedin1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression |
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 |
|---|---|---|
| trabectedinAlso: YONDELIS1.3 mg/mq as a 3 hour continuous infusion every three weeks | Drug | trabectedin |
| trabectedinAlso: ET 7431.3 mg/mq as a 3 hour continuous infusion every three weeks until progression | Drug | trabectedin |
Primary outcome
Progression-free survival (PFS) rate at 6 months
Time frame: every 9 weeks
CT scan
6 secondary outcomes
Safety profile
Time frame: every 3 weeks
Response rate and response duration
Time frame: every 2 months
Overall survival
Time frame: every 3 weeks during therapy, every 2-3 months thereafter
PFS rate at 9 and 18 weeks
Time frame: every 9 weeks
Identify biomarkers predictive for resistance or sensitivity to trabectedin
Time frame: at trial start
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity
Time frame: based on a pre-definid sample collection schedule
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 11 Aug 2014.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
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 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
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 trabectedin 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 11 Aug 2014. 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 (PFS) rate at 6 months (time frame: every 9 weeks). 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 11 Aug 2014.