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Scheduling Nab-paclitaxel With Gemcitabine (SIEGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529175
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

Brief 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 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.


Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Metastatic Drug: Abraxane (nab-paclitaxel) Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Concomitant
Intravenous 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.
Drug: Abraxane (nab-paclitaxel)
Drug: Gemcitabine
Active Comparator: Sequential
Intravenous 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.
Drug: Abraxane (nab-paclitaxel)
Drug: Gemcitabine



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From participant randomisation to the point at which disease progression is reported (i.e. 12 months) ]
    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.


Secondary Outcome Measures :
  1. Patient Safety [ Time Frame: 1 year after end of treatment visit ]
    Adverse Events (including Serious Adverse Events), abnormal laboratory test results and performance status

  2. Treatment Efficacy [ Time Frame: 8 weeks ]
    response to treatment assessed using radiological RECIST criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529175


Locations
Show Show 23 study locations
Sponsors and Collaborators
CCTU- Cancer Theme
Celgene
Investigators
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Principal Investigator: Pippa Corrie Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

Additional Information:
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Responsible Party: CCTU- Cancer Theme, CCTU-Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03529175    
Other Study ID Numbers: SIEGE (AX-PANC-PI-0101)
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs