Metastatic Pancreatic CancerPhase 2PACT-ACT-v6NCT02707159
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
A Phase 2 study testing Nab paclitaxel / gemcitabine in people with Metastatic Pancreatic Cancer, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Nab paclitaxel / gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2014to Jan 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years up to 80 years
- Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
- Locally advanced (primarily unresectable) and/or metastatic disease.
- Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
- ECOG/WHO performance status ≤2
- Absolute neutrophil count (ANC) >1.5 x 109 /L and platelet count >100 x 109/L
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- Total bilirubin < 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT < 2 x ULN. If liver metastases are present, patients can be included if total bilirubin < 5× ULN or AST/ALT <10× ULN. Dose reductions of paclitaxel will be performed when bilirubin >2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
- Serum creatinin < 1,5 ULN / calculated creatine clearance > 60 ml/min.
- Written informed consent
Who cannot join
- Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
- Prior medical treatment for advanced pancreatic cancer
- Confirmed brain metastasis.
- Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
- Treatment with any other investigational drug more than 30 days prior to study entry.
- Allergy to anyone of the included drugs.
- Female patient breast feeding or pregnancy
- Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Therapy for Locally Advanced and Metastatic Pancreatic Cancer Based on Nanoparticle Albumin-bound Paclitaxel and Gemcitabine: Circulating Tumor Cells as a Potential Biomarker for Treatment Monitoring, -Response and Survival
The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%. Treatment with chemotherapy can improve efficacy, but still the median progression-free survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median overall survival is less than one year. There is a urgent need for tools for predicting the efficacy of the treatment. The current trial aims at investigating the biomarker potential of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by gemcitabine and nab-paclitaxel.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Nab paclitaxel / gemcitabine
- Keywords
- Circulating tumor cells, Nab-paclitaxel, Metastatic pancreatic cancer, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxel / gemcitabineDrug
Also called Nab-paclitaxel and Gemcitabine
Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Nab paclitaxel / gemcitabine | Experimental | Patients will receive 125 mg per m2 nab-paclitaxel and 1000 mg per m2 on days 1, 8 and 15 followed by one week of rest before new treatment cycle. Receives: Drug: Nab paclitaxel / gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of circulating tumor cells (CTCs) during treatment
Measured: Baseline and 9 months
Secondary outcomes (5)
Post-baseline over-all survival
Measured: Baseline and 9 months
Post-baseline disease-specific survival
Measured: Baseline and 9 months
Post-baseline time to progression
Measured: Baseline and 9 months
Clinical response to treatment by RECIST 1.1
Radiologic, clinical and biochemical assessment
Measured: Baseline and 9 months
Changes in quality of life during treatment
Quality of Life is assessed every 4 weeks during treatment and then every 8th weeks.
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionOct 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bjørnar Gilje, MD, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707159
- Sponsor's protocol ID
- 2013/1743
- Other IDs
- 2013-000633-13
- Acronym
- PACT-ACT-v6
- Status last verified
- Mar 2016
- First submitted
- 22 Nov 2015
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Therapy for Locally Advanced and Metastatic Pancreatic Cancer Based on Nanoparticle Albumin-bound Paclitaxel and Gemcitabine: Circulating Tumor Cells as a Potential Biomarker for Treatment Monitoring, -Response and Survival
- ClinicalTrials.gov ID
- NCT02707159
- Acronym / sponsor ID
- PACT-ACT-v6 / 2013/1743
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Circulating tumor cells, Nab-paclitaxel, Metastatic pancreatic cancer, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Nov 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 14 Mar 2016 (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.
The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%. Treatment with chemotherapy can improve efficacy, but still the median progression-free survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median overall survival is less than one year. There is a urgent need for tools for predicting the efficacy of the treatment. The current trial aims at investigating the biomarker potential of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by gemcitabine and nab-paclitaxel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab paclitaxel / gemcitabine | Experimental | Drug: Nab paclitaxel / gemcitabinePatients will receive 125 mg per m2 nab-paclitaxel and 1000 mg per m2 on days 1, 8 and 15 followed by one week of rest before new treatment cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female > 18 years up to 80 years
- Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
- Locally advanced (primarily unresectable) and/or metastatic disease.
- Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
- ECOG/WHO performance status ≤2
Key exclusion criteria (8 listed)
- Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
- Prior medical treatment for advanced pancreatic cancer
- Confirmed brain metastasis.
- Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
- Treatment with any other investigational drug more than 30 days prior to study entry.
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 |
|---|---|---|
| Nab paclitaxel / gemcitabineAlso: Nab-paclitaxel and GemcitabinePatients will receive gemcitabine/nab-paclitaxel combination chemotherapy | Drug | Nab paclitaxel / gemcitabine |
Primary outcome
Change in levels of circulating tumor cells (CTCs) during treatment
Time frame: Baseline and 9 months
5 secondary outcomes
Post-baseline over-all survival
Time frame: Baseline and 9 months
Post-baseline disease-specific survival
Time frame: Baseline and 9 months
Post-baseline time to progression
Time frame: Baseline and 9 months
Clinical response to treatment by RECIST 1.1
Time frame: Baseline and 9 months
Changes in quality of life during treatment
Time frame: Baseline and 9 months
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 8 Mar 2023.
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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.
Bjørnar Gilje, MD, PhD principal investigator
Helse Stavanger HF
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 Nab paclitaxel / gemcitabine in people with Metastatic Pancreatic Cancer, run by Helse Stavanger HF at 1 site in Norway.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 8 Mar 2023. 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 Norway. 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?
Change in levels of circulating tumor cells (CTCs) during treatment (time frame: Baseline and 9 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 8 Mar 2023.