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Pancreatic AdenocarcinomaPhase 2PRICKLENCT02124369

Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE)

A Phase 2 study testing Abraxane and Gemcitabine in people with Pancreatic Adenocarcinoma, run by CCTU- Cancer Theme at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Pancreatic cancer is difficult to treat, and even in a situation where an operation can be performed to remove the cancer, the disease can unfortunately come back soon afterwards. When pancreatic cancer is more advanced, the outcomes are even less positive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Abraxane and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2014to Dec 2017
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

Who may be able to join

  • Patients with borderline unresectable advanced pancreatic adenocarcinoma, defined as Category 2 by central radiological review.
  • Aged 18 years or over at the time of signing the informed consent form.
  • Documented histological or cytological diagnosis of pancreatic ductal adenocarcinoma.
  • ECOG performance status 0-1.
  • Life expectancy of at least 12 weeks.
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
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  • Adequate haematological function defined by:
  • Absolute neutrophil count (ANC) ≥1,500 cells/mm3 (1.5 x 109/L).
  • Haemoglobin ≥8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
  • Platelets ≥100x 109/L
  • Adequate renal function defined by serum creatinine≤1.5 x ULN or calculated creatinine clearance by Cockcroft-Gault of ≥50 ml/min.
  • Adequate hepatic function defined by:
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN)
  • Total bilirubin ≤1.5 x ULN
  • Patients may have endoscopic or radiologic stenting to treat biliary obstruction. If so, bilirubin must return to ≤1.5 x ULN prior to enrolment.
  • Received no prior therapy for their disease.
  • Measurable disease by RECIST 1.1 criteria. Tumour assessments and measurements must be done within 28 days before the patient receives the first dose of ABX/GEM.
  • All Women of Child Bearing Potential (WoCBP) and all sexually active male patients must agree to use effective contraception methods throughout the study and for 6 months after the final dose of trial drug.

Who cannot join

  • Patients with metastatic PDAC, or disease which is amenable to resection with curative intent. These include tumours which are defined as Category 1 or 3 by central radiological review.
  • Other invasive malignancies diagnosed within the last 5 years, with the exceptions of adequately treated localized cured prostate cancer, in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
  • Known allergy or hypersensitivity to ABX or GEM.
  • Routine use of oral anti-oxidant supplements: beta-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E, astaxanthin. If recent use, a washout period of 5 half-lives is required.
  • Patients with pre-existent ischemic heart disease particularly those under active treatment for coronary disease, will be excluded from Sonuvue dynamic contrast enhanced ultrasound investigation due to sporadic reports of cardiac ischemia in this population. They will be eligible for the rest of the study, as long as their cardiac status does not preclude surgery.
  • Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. Examples include, but are not limited to:
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  • Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation who are not appropriately anti-coagulated or have had a NCI CTCAE (version 4.0) Grade 2 or greater bleeding episode in the 4 weeks before Day 1.
  • Patients taking warfarin, unless it is possible for the patient to be switched to a low molecular weight heparin for the duration of the study
  • Patients with a significant history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
  • Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis B, or hepatitis C.
  • Known infection with HIV.
  • Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 6 months after the last dose).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

Other trials in United Kingdom

About this study

Official title: Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE) - A Single-centre Phase 2a Study of Gemcitabine Plus Nab-paclitaxel for Borderline Unresectable Locally Advanced Pancreatic Cancer

Pancreatic cancer is difficult to treat, and even in a situation where an operation can be performed to remove the cancer, the disease can unfortunately come back soon afterwards. When pancreatic cancer is more advanced, the outcomes are even less positive. Recently, a large international study showed that combining a chemotherapy drug that is standard for treating pancreatic cancer, called gemcitabine with a new chemotherapy drug called Abraxane was more effective than gemcitabine alone for patients with advanced pancreatic cancer.

The purpose of this study is to determine whether this combination of gemcitabine and Abraxane can shrink a pancreatic cancer that is not thought to be operable enough to enable it to be removed by surgery. It is hoped that in this way, the treatment may improve the outcome. In addition, in this study we would like to analyse the appearances of the tumour using imaging, and collect blood and tumour samples to try to confirm laboratory research that has been carried out with this treatment.

Read the detailed description

This is a single-centre, non-randomised, phase 2a, single arm, Simon two-stage design trial of nab-paclitaxel and gemcitabine (ABX/GEM) in patients with histological documentation of pancreatic ductal adenocarcinoma (PDAC) who are determined by central radiological review to have "category 2" borderline unresectable LAPC. We will investigate the feasibility of administering ABX/GEM in terms of safety and efficacy, and will study activity both in terms of radiological response and the feasibility of downstaging patients to "category 1" status, in order to attempt resection after up to 6 cycles of combination treatment. In addition to adding to data on the safety and tolerability of this combination, peri- and post-operative morbidity following this treatment will be evaluated. As part of the trial, detailed correlative studies will be undertaken to evaluate the mechanism of action of the combination, at a tissue level, a circulating biomarker level and a radiological level.

We propose that the tumour shrinkage (response) seen in Stage IV pancreatic cancer patients as a result of ABX/GEM may translate to a realistic prospect of downstaging borderline unresectable LAPC tumours sufficiently to enable resection. Notionally, even in the absence of a classical partial response by RECIST criteria (≥30% reduction in sum of longest diameters) a beneficial outcome may arise from any tumour shrinkage sufficient to permit the tumour to be separated from major vessels thus rendering it resectable. Such an outcome may significantly alter the poor survival outcomes in this group of patients. The PRICKLE clinical study paradigm is useful for evaluating novel agents and combinations that show impressive activity in the pre-clinical or advanced setting and offers an opportunity for detailed correlative translational studies to evaluate activities of therapy.

Being tested
Abraxane, Gemcitabine
Keywords
Pancreatic cancer, locally advanced, unresectable
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbraxaneDrug

    Also called nab-paclitaxel

    125mg/m2, IV, on days 1,8 \& 15 of each 28 day cycle, up to 6 cycles.

  • GemcitabineDrug

    Also called Gemzar

    1000mg/m2, IV, on days 1,8 \& 15 of a 28 day cycle, up to 6 cycles.

Study groups in NCT02124369
Study groupRoleWhat they receive
Abraxane & gemictabineOtherAbraxane, IV, 125mg/m2 and gemcitabine, IV, 1000mg/m2, on days 1,8 \& 15 per 28 day cycle, up to a maximum of 6 cycles.
Receives: Drug: Abraxane; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumour resection rate

    Is the combination of ABX/GEM effective in shrinking LAPC tumours sufficiently to permit resection.

    Measured: 18 months

Secondary outcomes (1)

  1. Number of Participants with Serious and Non-Serious Adverse Events

    Determining the causality of Adverse Events and Serious Adverse Events

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2017
  4. Study completionDec 2017

Why it stopped: Poor accrual

Resources

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02124369
Sponsor's protocol ID
PRICKLE
Other IDs
2013-004200-19
Acronym
PRICKLE
Status last verified
Jul 2019
First submitted
15 Apr 2014
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abraxane and Gemcitabine in people with Pancreatic Adenocarcinoma, run by CCTU- Cancer Theme at 1 site in United Kingdom.

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 18 inclusion and 12 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: stopped early, as of the sponsor's last update on 16 Jul 2019. 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 United Kingdom. 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: Poor accrual). 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?

Tumour resection rate (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02124369.

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 16 Jul 2019.

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