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

Primary Purpose

Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Albumin-bound paclitaxel (ABI-007)
Gemcitabine
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB Comprenhensive Cancer Center at University of Alabama
  • Clearview Cancer Institute Oncology Specialities, P.C.
  • TGEN Clinical Research Services at Scottsdale Healthcare
  • Mayo Clinic-Scottsdale
  • Northern Arizona Hematology and Oncology Associates-AOA
  • Arizona Cancer Center, University of Arizona
  • Genesis Cancer Center
  • Tower Cancer Research Foundation
  • City of Hope
  • Pacific Shores Medical Group
  • UCLA
  • Desert Hematology Oncology Medical Group, Inc.
  • University of Colorado Cancer Center
  • Rocky Mountain Cancer Center
  • University Cancer Institute, LLC
  • Collaborative Research Group
  • FL Cancer Specialist
  • Lakeland Regional Cancer Center
  • Ocala Oncology Center
  • Florida Hospital Cancer Institute
  • Lake County Oncology and Hematology
  • Phoebe Putney Cancer Center
  • Northeast Georgia Cancer Care, LLC
  • Piedmont Hospital Research Institute
  • Georgia Cancer Specialists
  • Atlanta Cancer Care
  • Cancer Care & Hemaotology Specialists of Chicagoland
  • NorthShore University HealthSystem
  • Cancer Care & Hematology Specialists of Chicagoland
  • Illinois Cancer Care
  • Orchard Research
  • Indiana University Simon Cancer Center
  • Hutchinson Clinic, PA
  • Owsley Brown Frazier Cancer Center
  • Hematology Oncology Clinic
  • Mary Bird Perkins Cancer Center
  • Central Maine Medical Center
  • Mercy Hospital Portland, ME
  • Maine Center for Cancer Medicine
  • Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
  • Center for Cancer & Blood Disorders
  • Lahey Clinic
  • Cancer Center of Excellence/University of MA Medical School
  • St. Mary's/ Duluth Clinic
  • Virginia Piper Cancer Institute
  • University of Minnesota, Masonic Cancer Center
  • Saint Louis University
  • St. John's Medical Research Institute
  • The Center for Cancer and Hematologic Disease
  • Hem Onc Associates-NM
  • University of New Mexico
  • New York Oncology Hematology PC
  • Roswell Park Cancer Institute
  • Arena Oncology Associates, PC
  • SUNY Upstate Medical University
  • Piedmont Hematology Oncology
  • Oncology Hematology Care
  • Mid Ohio Oncology/Hematology Inc
  • Kettering Medical Center
  • Signal Point Clinical Research Center, LLC
  • Cancer Centers of SW OK
  • University of Oklahoma Health Science Center
  • Mercy Physicians of Oklahoma
  • Cancer Care Associates- Tulsa
  • St. Mary Medical Center Hem-Onc Group, PC
  • University of Pittsburg Medical Center
  • South Carolina Oncology Associates
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology
  • Medical City Dallas-US Oncology
  • Texas Oncology, PA
  • Texas Oncology, PA/ Methodist Charlton Cancer Center
  • Texas Oncology Laboratories
  • The Center for Cancer and Blood Disorders
  • The University of Texas Medical School at Houston
  • Texas Oncology- Plano East
  • Texas Oncology, PA
  • Texas Oncology-Round Rock
  • South Texas Oncology and Hematology, P.A
  • Texas Oncology, PA
  • Utah Cancer Specialists
  • Huntsman Cancer Institute
  • Fairfax-Northern Virginia Hematology-Oncology, P.C.
  • Virginia Cancer Specialist, PC
  • Virginia Cancer Institute
  • Virginia Commonwealth University
  • Swedish Health Services
  • Fred Hutchinson Cancer Research Center
  • Evergreen Hematology & Oncology
  • Medical College of Wisconsin
  • Bankstown-Lidcombe Hospital
  • Macarthur Cancer Therapy Center
  • Concord Hospital
  • St. Vincent's Hospital
  • Prince of Wales Hospital
  • Newcastle Hospital
  • Southern Medical Day Care Centre
  • Royal Brisbane and Women's Hospital
  • Haemotology & Oncology Australasia (HOCA)
  • Haematology Oncology Clinics of Australasia-Gold Coast
  • Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
  • Flinders Medical Center
  • Calvary North Adelaide Hospital
  • Royal Hobart Hospital
  • Medical Oncology Unit, Bendigo Health
  • Monash Medical Centre
  • Western Hospital
  • Peninsula Oncology Centre
  • Alfred Hospital
  • Border Medical Oncology
  • Sir Charles Gairdner Hospital
  • Krankenhaus der Barmherzigen Schwestern Linz
  • Landesklinikum St. Pölten
  • Medizinische Universität Wien
  • Klinikum Wels-Grieskirchen GmbH
  • Imelda VZW , Gastro-Enterology
  • Hôpital Erasme, Gastro-Enterology
  • AZ Groeninge - Campus Sint-Niklaas
  • H.-Hartziekenhuis Roeselare-Menen vzw
  • Tom Baker Cancer Centre
  • BC Cancer Agency-Vancouver
  • The Royal Victoria Hospital-Barrie
  • Hopital du Sacre-Coeur
  • Centre Hospitalier de L'Universite de Montreal St-Luc
  • Princess Margaret Hospital
  • Hotel-Dieu de Quebec
  • Centre Regional de lutte contre le cancer Paul Papin
  • Hôpital Saint Antoine
  • Hôpital Beaujon
  • Kliniken Essen-Mitte
  • Klinikum Freising
  • Praxis für Innere Medizin, Dr. Oettle Helmut
  • LMU Klinikum der Universität
  • Klinikum Oldenburg
  • Universitätsklinikum Würzburg
  • I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
  • E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
  • Nazionale per la Ricerca sul Cancro
  • Fondazione Centro San Raffaele del Monte Tabor
  • Oncologia Medica Falck
  • Istituto Oncologico Veneto
  • IRCCS Policlinico San Matteo
  • Azienda Ospedaliero universitaria Pisana
  • Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica
  • Arcispedale Santa Maria Nuova
  • Istituto Nazionale Tumori "Regina Elena"
  • Istituto Clinico Humanitas
  • Ospedale Casa Sollievo della Sofferenza IRCCS
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Med Radiological Centre of the Russian Academy of Med Sciences
  • Tatarstan Republican Onc Ctr
  • Altai Territorial Oncological Center
  • Chelyabinsk Regional Onc Ctr
  • Ivanovo Regional Oncology Center
  • Regional Oncological Center # 2
  • Moscow Municipal Onc Hosp #62
  • Moscow City Clinical Hosp #57 Chemotherapy Dept
  • Blokhin Cancer Research Center
  • Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
  • Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
  • Central Clinical Hosp of the President of the Russian Federation
  • Semashko Central Hosp #2
  • Omsk Regional Onc Ctr
  • Orenburg Regional Onc Ctr
  • Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
  • St. Petersburg State Med Academy n.a.Mechnikov
  • Russian Research Ctr for Radiology and Surgical Technologies
  • Clinical Hosp # 122 n.a. L.G. Sokolov
  • Leningrad Regional Clinical Hosp
  • St. Petersburg City Onc Ctr
  • Tula Regional Oncology Center
  • Bashkortostan Republican Onc Ctr
  • Yaroslavl Regional Onc Ctr
  • Hospital Vall D´Hebron
  • Hospital Clinic i Provincial
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Ramón y Cajal
  • Hospital Clinico San Carlos
  • Hospital 12 de Octubre
  • Centro Integral Oncológico Clara Campal
  • Hospital Virgen del Rocio
  • Dnepropetrovsk City Hosp #4
  • Donetsk Regional Antitumor Ctr
  • Kirovohrad Regional Oncology Center, Department of Chemotherapy
  • National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
  • Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
  • Volyn Regional Oncology Center Department of Oncochemotherapy
  • Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
  • O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
  • Kharkov Regional Onc Ctr
  • Kherson Regional Onc Ctr
  • Odessa Regional Onc Ctr
  • Zaporizhia Medical Academy of Postgraduate Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Albumin-bound paclitaxel (ABI-007)/Gemcitabine

Gemcitabine

Arm Description

ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.

Gemcitabine, 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 13, 2009
Last Updated
November 7, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00844649
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2009 (Actual)
Primary Completion Date
September 17, 2012 (Actual)
Study Completion Date
April 9, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
861 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin-bound paclitaxel (ABI-007)/Gemcitabine
Arm Type
Experimental
Arm Description
ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine, 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).
Intervention Type
Drug
Intervention Name(s)
Albumin-bound paclitaxel (ABI-007)
Other Intervention Name(s)
Abraxane
Intervention Description
ABI-007 125 mg/m^2 administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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).
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) by Independent Radiological Review (IRR)
Description
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.
Time Frame
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.
Title
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
Description
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.
Time Frame
Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Other Pre-specified Outcome Measures:
Title
Participants With Treatment Emergent Adverse Events (AE)
Description
A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
Time Frame
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Title
Number of Participants With Dose Reductions
Description
The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time Frame
Maximum time on treatment was 666 days
Title
Number of Participants With Dose Interruptions
Description
The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time Frame
Maximum time on treatment was 666 days
Title
Number of Participants With Dose Delays/Doses Not Given
Description
The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
Time Frame
Up to 666 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. 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. Exclusion Criteria 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Von Hoff, MD
Organizational Affiliation
Scottsdale Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Comprenhensive Cancer Center at University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Clearview Cancer Institute Oncology Specialities, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TGEN Clinical Research Services at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic-Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Northern Arizona Hematology and Oncology Associates-AOA
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Arizona Cancer Center, University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University Cancer Institute, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Collaborative Research Group
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
FL Cancer Specialist
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Lake County Oncology and Hematology
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Phoebe Putney Cancer Center
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Piedmont Hospital Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Atlanta Cancer Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Cancer Care & Hemaotology Specialists of Chicagoland
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60021
Country
United States
Facility Name
Cancer Care & Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Orchard Research
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Hutchinson Clinic, PA
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Owsley Brown Frazier Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Mercy Hospital Portland, ME
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Maine Center for Cancer Medicine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Center for Cancer & Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Cancer Center of Excellence/University of MA Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
St. Mary's/ Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55408
Country
United States
Facility Name
University of Minnesota, Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
The Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Hem Onc Associates-NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
New York Oncology Hematology PC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Piedmont Hematology Oncology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Mid Ohio Oncology/Hematology Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Cancer Centers of SW OK
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Mercy Physicians of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates- Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
St. Mary Medical Center Hem-Onc Group, PC
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Medical City Dallas-US Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2510
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4400
Country
United States
Facility Name
Texas Oncology, PA/ Methodist Charlton Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Texas Oncology Laboratories
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology- Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology, PA
City
Round Rock
State/Province
Texas
ZIP/Postal Code
76885
Country
United States
Facility Name
Texas Oncology-Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
South Texas Oncology and Hematology, P.A
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology, PA
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Fairfax-Northern Virginia Hematology-Oncology, P.C.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Cancer Specialist, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Evergreen Hematology & Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Macarthur Cancer Therapy Center
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Newcastle Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Haemotology & Oncology Australasia (HOCA)
City
Milton
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Haematology Oncology Clinics of Australasia-Gold Coast
City
Milton
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Flinders Medical Center
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Calvary North Adelaide Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Medical Oncology Unit, Bendigo Health
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3552
Country
Australia
Facility Name
Monash Medical Centre
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Peninsula Oncology Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands, Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Landesklinikum St. Pölten
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Imelda VZW , Gastro-Enterology
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Hôpital Erasme, Gastro-Enterology
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
AZ Groeninge - Campus Sint-Niklaas
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare-Menen vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer Agency-Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
The Royal Victoria Hospital-Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M6M2
Country
Canada
Facility Name
Hopital du Sacre-Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier de L'Universite de Montreal St-Luc
City
Montreal
ZIP/Postal Code
H2X3J4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre Regional de lutte contre le cancer Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hôpital Beaujon
City
Paris
ZIP/Postal Code
92118
Country
France
Facility Name
Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinikum Freising
City
Freising
ZIP/Postal Code
85354
Country
Germany
Facility Name
Praxis für Innere Medizin, Dr. Oettle Helmut
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
LMU Klinikum der Universität
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Oncologia Medica Falck
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Istituto Nazionale Tumori "Regina Elena"
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza IRCCS
City
San Giovanni Rotondo, Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Med Radiological Centre of the Russian Academy of Med Sciences
City
Obninsk
State/Province
Kaluga Region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Tatarstan Republican Onc Ctr
City
Kazan
State/Province
Republic Of Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Altai Territorial Oncological Center
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Chelyabinsk Regional Onc Ctr
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Center
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Regional Oncological Center # 2
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
Facility Name
Moscow Municipal Onc Hosp #62
City
Moscow Region
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Moscow City Clinical Hosp #57 Chemotherapy Dept
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Central Clinical Hosp of the President of the Russian Federation
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Semashko Central Hosp #2
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Omsk Regional Onc Ctr
City
Omsk
ZIP/Postal Code
610013
Country
Russian Federation
Facility Name
Orenburg Regional Onc Ctr
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
St. Petersburg State Med Academy n.a.Mechnikov
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Russian Research Ctr for Radiology and Surgical Technologies
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Clinical Hosp # 122 n.a. L.G. Sokolov
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hosp
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St. Petersburg City Onc Ctr
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tula Regional Oncology Center
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Bashkortostan Republican Onc Ctr
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Yaroslavl Regional Onc Ctr
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Vall D´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Dnepropetrovsk City Hosp #4
City
Dnepropetrovsk
State/Province
UK
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Ctr
City
Donetsk
State/Province
UK
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Kirovohrad Regional Oncology Center, Department of Chemotherapy
City
Kirovohrad
State/Province
UK
ZIP/Postal Code
25031
Country
Ukraine
Facility Name
National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
City
Kyiv
State/Province
UK
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
City
Kyiv
State/Province
UK
ZIP/Postal Code
3039
Country
Ukraine
Facility Name
Volyn Regional Oncology Center Department of Oncochemotherapy
City
Lutsk
State/Province
UK
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
City
Lviv
State/Province
UK
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
City
Zhytomyr
State/Province
UK
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Kharkov Regional Onc Ctr
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kherson Regional Onc Ctr
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Odessa Regional Onc Ctr
City
Odessa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Zaporizhia Medical Academy of Postgraduate Education
City
Zaporizhia
ZIP/Postal Code
69096
Country
Ukraine

12. IPD Sharing Statement

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

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