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Pancreatic Adenocarcinoma MetastaticPhase 2SIEGENCT03529175

Scheduling Nab-paclitaxel With Gemcitabine

A Phase 2 study testing Abraxane (nab-paclitaxel) and Gemcitabine in people with Pancreatic Adenocarcinoma Metastatic, run by CCTU- Cancer Theme at 23 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Metastatic pancreatic cancer is difficult to treat. Until recently, most patients would be offered treatment with a chemotherapy drug called gemcitabine. However, a large international trial showed that combining gemcitabine with a drug called nab-paclitaxel (or abraxane) was more effective compared with gemcitabine… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma Metastatic
What is being tested?
Abraxane (nab-paclitaxel) and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
23 sitesUnited Kingdom
Study dates
Jan 2014to Jun 2016
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

  • Aged ≥ 18 years old
  • Signed informed consent and ability to comply with the protocol
  • Histologically or cytologically confirmed metastatic PDAC
  • Radiologically confirmed stage IV disease and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; baseline tumour assessments and measurements must be done within 28 days prior to randomisation
  • Karnofsky performance status ≥70%
  • Life expectancy >12 weeks from the date of screening assessment
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  • Adequate bone marrow function
  • Absolute neutrophil count (ANC) ≥1.5 x 109 /L
  • Haemoglobin (Hb) ≥ 100 g/L
  • Platelets ≥100 x 109 /L
  • White blood cell count (WBC) ≥ 3 x 109 /L
  • Adequate liver function
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal range (ULN)
  • Total bilirubin <1.5 x ULN
  • Adequate renal function defined as a serum creatinine ≤1.5 x ULN or calculated creatinine clearance by Cockcroft-Gault of ≥50 mL/min
  • Received no prior systemic therapy for metastatic disease
  • Prior adjuvant chemotherapy (with GEM or any other drug/s) is allowed if completed at least 6 months previously
  • Prior radiotherapy is allowed as long as there is measurable disease which has not been irradiated
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, completion of QoL and HE questionnaires and other study procedures
  • Confirmation of tumour tissue sample collected within 12 weeks prior to randomisation and blood to be taken prior to randomisation
  • Women of child-bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if age ≤55 years or 12 months if age >55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation
  • All WCBP and all sexually active male patients must agree to use effective contraception methods throughout the study and for 30 days after the final dose of study drug for WCBP and for up to 6 months after treatment for male patients

Who cannot join

  • Patients with operable or locally advanced PDAC
  • Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate cancer
  • 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 trial. Examples include, but are not limited to:
  • Patients who have had a venous thromboembolic event who are not appropriately anticoagulated or have had a significant bleeding episode in the 3 weeks prior to randomisation
  • Patients with symptoms of severe chronic obstructive airways disease or significant shortness of breath at rest AND have an FEV1<1.0 L within the last 6 months
  • Patients with a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis
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  • Patients with uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction (MI), new angina, stroke transient ischaemic attack (TIA), or new congestive cardiac failure (CCF)) within the last 6 months
  • Patients with stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification (NYHF) III or IV, see Appendix 3) or frequent angina
  • Presence of active infection
  • Cirrhotic liver disease, known chronic active or acute hepatitis B, or hepatitis C
  • Known allergy or hypersensitivity to GEM or ABX
  • Women who are pregnant, plan to become pregnant or are lactating
  • Routine use of any of the following will exclude patients:
  • Oral anti-oxidant supplements: beta-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E, astaxanthin

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United Kingdom23 sites

  • Ysbyty Gwynedd

    Bangor

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Queen Elizabeth Hospital

    Birmingham

  • Bristol Haematology & Oncology Centre

    Bristol

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff

  • Colchester Hospital

    Colchester, CO4 5JL

  • University Hospitals Coventry & Warwickshire

    Coventry, CV2 2DX

  • Edinburgh Cancer Research Centre

    Edinburgh

  • The Beatson Oncology Centre

    Glasgow

  • The Royal Surrey County Hospital

    Guildford

  • St James' Institute of Oncology

    Leeds

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Clatterbridge Cancer Centre

    Liverpool

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Hammersmith Hospital

    London

  • The Royal Free Hospital

    London

  • University College London Hospital

    London

  • The Christie Hospital

    Manchester

  • Churchill Hospital

    Oxford

  • Peterborough City Hospital

    Peterborough, Cambridgeshire, PE3 9GZ

  • Weston Park Hospital

    Sheffield

  • Royal Cornwall Hospital

    Truro

Other trials in United Kingdom

About this study

Official title: Randomised Phase II Trial to Investigate Two Different Schedules of Nab-paclitaxel (Abraxane) Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic pancreatic cancer is difficult to treat. Until recently, most patients would be offered treatment with a chemotherapy drug called gemcitabine. However, a large international trial showed that combining gemcitabine with a drug called nab-paclitaxel (or abraxane) was more effective compared with gemcitabine alone. The purpose of this study is to compare two different ways of combining gemcitabine with abraxane. Conventionally, both drugs are given on the same day via a drip into a vein in the arm but research suggests that giving abraxane 24 hours in advance of gemcitabine could possibly be more beneficial.

In this study, blood and tumour samples will be collected and analysed to try to confirm what has been seen in the laboratory studies. In addition, the investigators wish to find out whether certain tumour characteristics (called biomarkers) can be used to predict for response to chemotherapy.

Being tested
Abraxane (nab-paclitaxel), Gemcitabine

What participants receive

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

Study groups in NCT03529175
Study groupRoleWhat they receive
ConcomitantActive comparatorIntravenous Abraxane125 mg/m2 30-minute infusion followed immediately by intravenous Gemcitabine 1000 mg/m2 30-minute infusion will be administered on days 1, 8 and 15 of a 4-week cycle.
Receives: Drug: Abraxane (nab-paclitaxel); Drug: Gemcitabine
SequentialActive comparatorIntravenous Abraxane 125 mg/m2 30-minute infusion will be administered on days 1, 8 and 15 of a 4-week cycle. Intravenous Gemcitabine 1000 mg/m2 30-minute infusion will be administered on days 2, 9 and 16 of a 4-week cycle. Gemcitabine must be delivered 24 +/- 2 hours after commencing Abraxane infusion.
Receives: Drug: Abraxane (nab-paclitaxel); Drug: Gemcitabine

What is being measured

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

  1. Progression free survival

    The primary objective of the trial is to investigate the outcome of sequential administration of nab-paclitaxel combined with gemcitabine (ABX/GEM, 24 hours apart) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in terms of progression-free survival.

    Measured: From participant randomisation to the point at which disease progression is reported (i.e. 12 months)

Secondary outcomes (2)

  1. Patient Safety

    Adverse Events (including Serious Adverse Events), abnormal laboratory test results and performance status

    Measured: 1 year after end of treatment visit

  2. Treatment Efficacy

    response to treatment assessed using radiological RECIST criteria

    Measured: 8 weeks

Timeline

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

  1. First posted18 May 2018
  2. Study startJan 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529175
Sponsor's protocol ID
SIEGE (AX-PANC-PI-0101)
Acronym
SIEGE
Status last verified
Jul 2019
First submitted
1 May 2014
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Dayimu A, Di Lisio L, Anand S, Roca-Carreras I, Qian W, Al-Mohammad A, Basu B, Valle JW, Jodrell D, Demiris N, Corrie P. Clinical and biological markers predictive of treatment response associated with metastatic pancreatic adenocarcinoma. Br J Cancer. 2023 May;128(9):1672-1680. doi: 10.1038/s41416-023-02170-9. Epub 2023 Feb 22.

    PubMed 36813867

  • Corrie PG, Qian W, Basu B, Valle JW, Falk S, Lwuji C, Wasan H, Palmer D, Scott-Brown M, Wadsley J, Arif S, Bridgewater J, Propper D, Gillmore R, Gopinathan A, Skells R, Bundi P, Brais R, Dalchau K, Bax L, Chhabra A, Machin A, Dayim A, McAdam K, Cummins S, Wall L, Ellis R, Anthoney A, Evans J, Ma YT, Isherwood C, Neesse A, Tuveson D, Jodrell DI. Scheduling nab-paclitaxel combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma. Br J Cancer. 2020 Jun;122(12):1760-1768. doi: 10.1038/s41416-020-0846-2. Epub 2020 Apr 30.

    PubMed 32350413

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abraxane (nab-paclitaxel) and Gemcitabine in people with Pancreatic Adenocarcinoma Metastatic, run by CCTU- Cancer Theme at 23 sites 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 22 inclusion and 14 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 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 23 sites 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 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 (time frame: From participant randomisation to the point at which disease progression is reported (i.e. 12 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 NCT03529175, which also lists 2 linked publications.

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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