Clinical trial NCT00844649: Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Official title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 861
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III Metastatic Pancreatic Cancer

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.

Eligibility criteria: Inclusion Criteria

A participant will be eligible for inclusion in this study only if all of the following criteria are met:

1. 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.
2. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
3. 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).
4. 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.
5. 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.
6. 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.
7. 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.
8. 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%).
9. Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization).
10. 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.
11. 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.
12. 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.

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. 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).
2. Patient has only locally advanced disease.
3. Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization.
4. Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization.
5. 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.
6. Patient uses Coumadin.
7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
8. Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
9. 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.
10. 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.
11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
12. Patients with a history of interstitial lung disease.
13. History of chronic leukemias (e.g., chronic lymphocytic leukemia).
14. Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
16. 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.
17. Patient is enrolled in any other clinical protocol or investigational trial.
18. 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary outcomes:
measure: Progression-free Survival (PFS) by Independent Radiological Review (IRR)
timeFrame: 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.
measure: Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
timeFrame: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Other outcomes:
measure: Participants With Treatment Emergent Adverse Events (AE)
timeFrame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
measure: Number of Participants With Dose Reductions
timeFrame: Maximum time on treatment was 666 days
measure: Number of Participants With Dose Interruptions
timeFrame: Maximum time on treatment was 666 days
measure: Number of Participants With Dose Delays/Doses Not Given
timeFrame: Up to 666 days
Locations:
city: Birmingham
country: United States
facility: UAB Comprenhensive Cancer Center at University of Alabama
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute Oncology Specialities, P.C.
state: Alabama
city: Scottsdale
country: United States
facility: TGEN Clinical Research Services at Scottsdale Healthcare
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic-Scottsdale
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology and Oncology Associates-AOA
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center, University of Arizona
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Boynton Beach
country: United States
facility: University Cancer Institute, LLC
state: Florida
city: Boynton Beach
country: United States
facility: Collaborative Research Group
state: Florida
city: Fort Myers
country: United States
facility: FL Cancer Specialist
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Tavares
country: United States
facility: Lake County Oncology and Hematology
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Cancer Center
state: Georgia
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Arlington Heights
country: United States
facility: Cancer Care & Hemaotology Specialists of Chicagoland
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Skokie
country: United States
facility: Orchard Research
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic, PA
state: Kansas
city: Louisville
country: United States
facility: Owsley Brown Frazier Cancer Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Portland
country: United States
facility: Mercy Hospital Portland, ME
state: Maine
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Baltimore
country: United States
facility: Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Worcester
country: United States
facility: Cancer Center of Excellence/University of MA Medical School
state: Massachusetts
city: Duluth
country: United States
facility: St. Mary's/ Duluth Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota, Masonic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Albuquerque
country: United States
facility: Hem Onc Associates-NM
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology PC
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology Inc
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of SW OK
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Physicians of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates- Tulsa
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary Medical Center Hem-Onc Group, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas-US Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA/ Methodist Charlton Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology Laboratories
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: The University of Texas Medical School at Houston
state: Texas
city: Plano
country: United States
facility: Texas Oncology- Plano East
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology, PA
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology-Round Rock
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, P.A
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology, PA
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Fairfax-Northern Virginia Hematology-Oncology, P.C.
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialist, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Spokane
country: United States
facility: Evergreen Hematology & Oncology
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Campbelltown
country: Australia
facility: Macarthur Cancer Therapy Center
state: New South Wales
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Milton
country: Australia
facility: Haemotology & Oncology Australasia (HOCA)
state: Queensland
city: Milton
country: Australia
facility: Haematology Oncology Clinics of Australasia-Gold Coast
state: Queensland
city: Ashford
country: Australia
facility: Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Center
state: South Australia
city: North Adelaide
country: Australia
facility: Calvary North Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Bendigo
country: Australia
facility: Medical Oncology Unit, Bendigo Health
state: Victoria
city: East Bentleigh
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Oncology Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Nedlands, Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz
city: St. Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Bonheiden
country: Belgium
facility: Imelda VZW , Gastro-Enterology
city: Brussels
country: Belgium
facility: Hôpital Erasme, Gastro-Enterology
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Sint-Niklaas
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen vzw
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Agency-Vancouver
state: British Columbia
city: Barrie
country: Canada
facility: The Royal Victoria Hospital-Barrie
state: Ontario
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal St-Luc
city: Ontario
country: Canada
facility: Princess Margaret Hospital
city: Quebec
country: Canada
facility: Hotel-Dieu de Quebec
city: Angers
country: France
facility: Centre Regional de lutte contre le cancer Paul Papin
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Beaujon
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Freising
country: Germany
facility: Klinikum Freising
city: Friedrichshafen
country: Germany
facility: Praxis für Innere Medizin, Dr. Oettle Helmut
city: Munich
country: Germany
facility: LMU Klinikum der Universität
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Bari
country: Italy
facility: I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
city: Genova
country: Italy
facility: E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
city: Genova
country: Italy
facility: Nazionale per la Ricerca sul Cancro
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Milano
country: Italy
facility: Oncologia Medica Falck
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero universitaria Pisana
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Istituto Nazionale Tumori "Regina Elena"
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo, Foggia
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza IRCCS
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Obninsk
country: Russian Federation
facility: Med Radiological Centre of the Russian Academy of Med Sciences
state: Kaluga Region
city: Kazan
country: Russian Federation
facility: Tatarstan Republican Onc Ctr
state: Republic Of Tatarstan
city: Barnaul
country: Russian Federation
facility: Altai Territorial Oncological Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Onc Ctr
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Center
city: Magnitogorsk
country: Russian Federation
facility: Regional Oncological Center # 2
city: Moscow Region
country: Russian Federation
facility: Moscow Municipal Onc Hosp #62
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hosp #57 Chemotherapy Dept
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center
city: Moscow
country: Russian Federation
facility: Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
city: Moscow
country: Russian Federation
facility: Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
city: Moscow
country: Russian Federation
facility: Central Clinical Hosp of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: Semashko Central Hosp #2
city: Omsk
country: Russian Federation
facility: Omsk Regional Onc Ctr
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Onc Ctr
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
city: St Petersburg
country: Russian Federation
facility: St. Petersburg State Med Academy n.a.Mechnikov
city: St Petersburg
country: Russian Federation
facility: Russian Research Ctr for Radiology and Surgical Technologies
city: St. Petersburg
country: Russian Federation
facility: Clinical Hosp # 122 n.a. L.G. Sokolov
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hosp
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg City Onc Ctr
city: Tula
country: Russian Federation
facility: Tula Regional Oncology Center
city: Ufa
country: Russian Federation
facility: Bashkortostan Republican Onc Ctr
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Onc Ctr
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Hosp #4
state: UK
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Ctr
state: UK
city: Kirovohrad
country: Ukraine
facility: Kirovohrad Regional Oncology Center, Department of Chemotherapy
state: UK
city: Kyiv
country: Ukraine
facility: National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
state: UK
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
state: UK
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncology Center Department of Oncochemotherapy
state: UK
city: Lviv
country: Ukraine
facility: Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
state: UK
city: Zhytomyr
country: Ukraine
facility: O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
state: UK
city: Kharkov
country: Ukraine
facility: Kharkov Regional Onc Ctr
city: Kherson
country: Ukraine
facility: Kherson Regional Onc Ctr
city: Odessa
country: Ukraine
facility: Odessa Regional Onc Ctr
city: Zaporizhia
country: Ukraine
facility: Zaporizhia Medical Academy of Postgraduate Education
Study officials:
affiliation: Scottsdale Clinical Research Institute
name: Daniel Von Hoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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