AzTrials
AzTrials

Metastatic Pancreatic CancerPhase 3NCT00844649

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

A Phase 3 study testing Albumin-bound paclitaxel (ABI-007) and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Celgene at 193 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

Phase III Metastatic Pancreatic Cancer Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Albumin-bound paclitaxel (ABI-007) and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
861 participants
Where
193 sitesin 11 countries
Study dates
1 Mar 2009to 9 Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A participant will be eligible for inclusion in this study only if all of the following criteria are met:
  • Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded.
  • Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
  • Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media).
  • Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug.
  • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.
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  • Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study.
  • Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained ≤14 days prior to randomization):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100,000/mm^3 (100 × 10^9/L); Hemoglobin (Hgb) ≥ 9 g/dL.
  • Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
  • Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed Total bilirubin ≤ ULN Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m^2, lean body weight should be used instead.
  • Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%).
  • Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization).
  • Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
  • Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1.
  • Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Who cannot join

  • A patient will not be eligible for inclusion in this study if any of the following criteria apply:
  • Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
  • Patient has only locally advanced disease.
  • Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization.
  • Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization.
  • History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
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  • Patient uses Coumadin.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
  • Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  • Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information.
  • History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
  • Patients with a history of interstitial lung disease.
  • History of chronic leukemias (e.g., chronic lymphocytic leukemia).
  • Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
  • History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
  • Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
  • Patient is enrolled in any other clinical protocol or investigational trial.
  • Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.

Trial locations and contacts

193 sites in 11 countries.

193 sites in 11 countries

United States90 sites

  • Phoebe Putney Cancer Center

    Albany, Georgia, 31701

  • New York Oncology Hematology PC

    Albany, New York, 12206

  • Hem Onc Associates-NM

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Cancer Care & Hemaotology Specialists of Chicagoland

    Arlington Heights, Illinois, 60005

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Piedmont Hospital Research Institute

    Atlanta, Georgia, 30309

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • Atlanta Cancer Care

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Sidney Kimmel Comphrensive Cancer Center, John Hopkins University

    Baltimore, Maryland, 21231

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • UAB Comprenhensive Cancer Center at University of Alabama

    Birmingham, Alabama, 35294

  • University Cancer Institute, LLC

    Boynton Beach, Florida, 33426

  • Collaborative Research Group

    Boynton Beach, Florida, 33435

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Mid Ohio Oncology/Hematology Inc

    Columbus, Ohio, 43219

  • Medical City Dallas-US Oncology

    Dallas, Texas, 75230-2510

  • Texas Oncology, PA

    Dallas, Texas, 75231-4400

  • Texas Oncology, PA/ Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • St. Mary's/ Duluth Clinic

    Duluth, Minnesota, 55805

  • NorthShore University HealthSystem

    Evanston, Illinois, 60021

  • Fairfax-Northern Virginia Hematology-Oncology, P.C.

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialist, PC

    Fairfax, Virginia, 22031

  • FL Cancer Specialist

    Fort Myers, Florida, 33916

  • Texas Oncology Laboratories

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Clearview Cancer Institute Oncology Specialities, P.C.

    Huntsville, Alabama, 35805

  • Hutchinson Clinic, PA

    Hutchinson, Kansas, 67502

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Arena Oncology Associates, PC

    Lake Success, New York, 11042

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • St. Mary Medical Center Hem-Onc Group, PC

    Langhorne, Pennsylvania, 19047

  • Cancer Centers of SW OK

    Lawton, Oklahoma, 73505

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • UCLA

    Los Angeles, California, 90024

  • Owsley Brown Frazier Cancer Center

    Louisville, Kentucky, 40245

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55408

  • University of Minnesota, Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Physicians of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Texas Oncology- Plano East

    Plano, Texas, 75075

  • Mercy Hospital Portland, ME

    Portland, Maine, 04102

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0037

  • Texas Oncology, PA

    Round Rock, Texas, 76885

  • Texas Oncology-Round Rock

    Round Rock, Texas, 78681

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • South Texas Oncology and Hematology, P.A

    San Antonio, Texas, 78229

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • TGEN Clinical Research Services at Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • Mayo Clinic-Scottsdale

    Scottsdale, Arizona, 85259

  • Swedish Health Services

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Northern Arizona Hematology and Oncology Associates-AOA

    Sedona, Arizona, 86336

  • Orchard Research

    Skokie, Illinois, 60076

  • Evergreen Hematology & Oncology

    Spokane, Washington, 99218

  • St. John's Medical Research Institute

    Springfield, Missouri, 65807

  • Saint Louis University

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Lake County Oncology and Hematology

    Tavares, Florida, 32778

  • Arizona Cancer Center, University of Arizona

    Tucson, Arizona, 85724

  • Cancer Care Associates- Tulsa

    Tulsa, Oklahoma, 74104

  • Texas Oncology, PA

    Wichita Falls, Texas, 76310

  • Piedmont Hematology Oncology

    Winston-Salem, North Carolina, 27103

  • Cancer Center of Excellence/University of MA Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Russia24 sites

  • Altai Territorial Oncological Center

    Barnaul, 656049

  • Chelyabinsk Regional Onc Ctr

    Chelyabinsk, 454087

  • Ivanovo Regional Oncology Center

    Ivanovo, 153013

  • Tatarstan Republican Onc Ctr

    Kazan', Tatarstan Republic, 420029

  • Regional Oncological Center # 2

    Magnitogorsk, 455001

  • Moscow City Clinical Hosp #57 Chemotherapy Dept

    Moscow, 105077

  • Blokhin Cancer Research Center

    Moscow, 115478

  • Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care

    Moscow, 117997

  • Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences

    Moscow, 119992

  • Central Clinical Hosp of the President of the Russian Federation

    Moscow, 121356

  • Semashko Central Hosp #2

    Moscow, 129128

  • Moscow Municipal Onc Hosp #62

    Moscow Region, 143423

  • Med Radiological Centre of the Russian Academy of Med Sciences

    Obninsk, Kaluga Oblast, 249036

  • Omsk Regional Onc Ctr

    Omsk, 610013

  • Orenburg Regional Onc Ctr

    Orenburg, 460021

  • Pyatigorsk Affiliate of Stavropol Regional Onc Ctr

    Pyatigorsk, 357500

  • Clinical Hosp # 122 n.a. L.G. Sokolov

    Saint Petersburg, 194291

  • Leningrad Regional Clinical Hosp

    Saint Petersburg, 194291

  • St. Petersburg State Med Academy n.a.Mechnikov

    Saint Petersburg, 195067

  • Russian Research Ctr for Radiology and Surgical Technologies

    Saint Petersburg, 197758

  • St. Petersburg City Onc Ctr

    Saint Petersburg, 198255

  • Tula Regional Oncology Center

    Tula, 300053

  • Bashkortostan Republican Onc Ctr

    Ufa, 450054

  • Yaroslavl Regional Onc Ctr

    Yaroslavl, 150054

Other trials in Russia

Australia21 sites

  • Adelaide Cancer Centre (T/A Ashford Cancer Ctr)

    Ashford, South Australia, 5035

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Flinders Medical Center

    Bedford Park, South Australia, 5042

  • Medical Oncology Unit, Bendigo Health

    Bendigo, Victoria, 3552

  • Macarthur Cancer Therapy Center

    Campbelltown, New South Wales, 2560

  • Concord Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Monash Medical Centre

    East Bentleigh, Victoria, 3165

  • Western Hospital

    Footscray, Victoria, 3011

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Haemotology & Oncology Australasia (HOCA)

    Milton, Queensland, 4101

  • Haematology Oncology Clinics of Australasia-Gold Coast

    Milton, Queensland, 4215

  • Sir Charles Gairdner Hospital

    Nedlands, Perth, Western Australia, 6009

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Newcastle Hospital

    Waratah, New South Wales, 2298

  • Border Medical Oncology

    Wodonga, Victoria, 3690

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Italy14 sites

  • I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico

    Bari, 70124

  • E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica

    Genova, 16128

  • Nazionale per la Ricerca sul Cancro

    Genova, 16132

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Oncologia Medica Falck

    Milan, 20162

  • Istituto Oncologico Veneto

    Padova, 35128

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero universitaria Pisana

    Pisa, 56126

  • Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica

    Reggio Emilia, 42100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Istituto Nazionale Tumori "Regina Elena"

    Roma, 00144

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Ospedale Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37134

Other trials in Italy

Ukraine12 sites

  • Dnepropetrovsk City Hosp #4

    Dnipro, UK, 49102

  • Donetsk Regional Antitumor Ctr

    Donetsk, UK, 83092

  • Kharkov Regional Onc Ctr

    Kharkiv, 61070

  • Kherson Regional Onc Ctr

    Kherson, 73000

  • Kirovohrad Regional Oncology Center, Department of Chemotherapy

    Kirovohrad, UK, 25031

  • National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum

    Kyiv, UK, 03022

  • Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery

    Kyiv, UK, 3039

  • Volyn Regional Oncology Center Department of Oncochemotherapy

    Lutsk, UK, 43018

  • Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr

    Lviv, UK, 79031

  • Odessa Regional Onc Ctr

    Odesa, 65055

  • Zaporizhia Medical Academy of Postgraduate Education

    Zaporizhia, 69096

  • O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center

    Zhytomyr, UK, 10008

Other trials in Ukraine

Spain8 sites

  • Hospital Vall D´Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial

    Barcelona, 8036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Canada7 sites

  • The Royal Victoria Hospital-Barrie

    Barrie, Ontario, L4M6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Hopital du Sacre-Coeur

    Montreal, Quebec, H4J 1C5

  • Centre Hospitalier de L'Universite de Montreal St-Luc

    Montreal, H2X3J4

  • Princess Margaret Hospital

    Ontario, M5G 2M9

  • Hotel-Dieu de Quebec

    Québec, G1R 2J6

  • BC Cancer Agency-Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany6 sites

  • Kliniken Essen-Mitte

    Essen, 45136

  • Klinikum Freising

    Freising, 85354

  • Praxis für Innere Medizin, Dr. Oettle Helmut

    Friedrichshafen, 88045

  • LMU Klinikum der Universität

    Munich, 81377

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Universitätsklinikum Würzburg

    Würzburg, 97070

Other trials in Germany

Austria4 sites

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Belgium4 sites

  • Imelda VZW , Gastro-Enterology

    Bonheiden, 2820

  • Hôpital Erasme, Gastro-Enterology

    Brussels, 1070

  • AZ Groeninge - Campus Sint-Niklaas

    Kortrijk, 8500

  • H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

France3 sites

  • Centre Regional de lutte contre le cancer Paul Papin

    Angers, 49933

  • Hôpital Saint Antoine

    Paris, 75571

  • Hôpital Beaujon

    Paris, 92118

Other trials in France

About this study

Official title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

Phase III Metastatic Pancreatic Cancer

Read the detailed description

A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Being tested
Albumin-bound paclitaxel (ABI-007), Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Albumin-bound paclitaxel (ABI-007)Drug

    Also called Abraxane

    ABI-007 125 mg/m^2 administered by intravenous infusion

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Study groups in NCT00844649
Study groupRoleWhat they receive
Albumin-bound paclitaxel (ABI-007)/GemcitabineExperimentalABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.
Receives: Drug: Albumin-bound paclitaxel (ABI-007); Drug: Gemcitabine
GemcitabineActive comparatorGemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Receives: Drug: Gemcitabine

What is being measured

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

  1. Overall Survival (OS)

    Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.

    Measured: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.

Secondary outcomes (2)

  1. Progression-free Survival (PFS) by Independent Radiological Review (IRR)

    Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.

    Measured: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.

  2. Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)

    Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.

    Measured: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months

Timeline

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

  1. First posted16 Feb 2009 (estimated)
  2. Study start1 Mar 2009
  3. Primary completion17 Sep 2012
  4. Study completion9 Apr 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844649
Sponsor's protocol ID
CA046
Status last verified
Nov 2019
First submitted
13 Feb 2009
Last updated
25 Nov 2019
Data monitoring committee
Yes

Publications

  • Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

    PubMed 25582141

  • Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28.

    PubMed 27351217

  • Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.

    PubMed 27085323

  • Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albumin-bound paclitaxel (ABI-007) and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Celgene at 193 sites in 11 countries.

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 16 inclusion and 19 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Russia, Australia, Italy, Ukraine and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (OS) (time frame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 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 NCT00844649, which also lists 16 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 25 Nov 2019.

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