Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

April 28, 2009 updated by: Threshold Pharmaceuticals

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.

Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.

Comparison: Glufosfamide versus best supportive care.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1650
        • Hospital Interzonal General de Agudos
      • Buenos Aires, Argentina, 1706
        • Hospital Posadas
      • Buenos Aires, Argentina, B8000FTS
        • Policlínica Privada Instituto de Medicina Nuclear
      • Buenos Aires, Argentina, C1120AAF
        • Hospital Udaondo
      • Buenos Aires, Argentina, C1406FWY
        • Hospital Alvarez
      • Buenos Aires, Argentina, C1437JCP
        • Hospital Churruca - Visca
      • Buenos Aires, Argentina
        • Instituto Medico Alexander Fleming
      • Santa Fe, Argentina
        • Instituto CAICI
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundacao Pio XII - Hospital de Cancer de Barretos
      • Belo Horizonte, Brazil, 30180-090
        • Hospital Vera Cruz - Clinica de Oncologia
      • Belo Horizonte, Brazil, 30380-490
        • Hospital Luxemburgo
      • Curitiba, Brazil, 80060-900
        • Hospital de Clinicas da UFPR
      • Goiania, Brazil, 74605-070
        • Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
      • Porto Alegre, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional do Cancer - INCA
      • Sao Paulo, Brazil, 01406100
        • Clinica de Oncologia Medica S/C Ltda
      • Sao Paulo, Brazil, 01509-900
        • Hospital do Cancer - AC Camargo
      • São Paulo, Brazil, 01331-020
        • Grupo Paulista Oncologia Integrada
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
      • Plovdiv, Bulgaria, 4004
        • First Internal Department Plovdiv Regional Oncology Center with In-patient Department
      • Sofia, Bulgaria, 1233
        • Department of Chemotherapy Sofia Regional Oncology Center
      • Sofia, Bulgaria, 1527
        • Chemotherapy Clinic Queen Joanna General Hospital
      • Sofia, Bulgaria, 1606
        • Haematology and Oncology Clinic Military Medical Academy
      • Sofia, Bulgaria, 1756
        • Chemotherapy Clinic Specialized Oncology Hospital
      • Tarnovo, Bulgaria, 5000
        • Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
      • Varna, Bulgaria, 9010
        • Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
  • Czech Republic
      • Brno, Czech Republic
        • Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
      • Brno, Czech Republic
        • Masarykuv onkologicky ustav
      • Kyjevska, Czech Republic
        • Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
      • Olomouc, Czech Republic
        • Onkologicka klinika, Fakultni Nemocnice Olomouc
      • Zlin, Czech Republic
        • Onkologicke Oddeleni, Batova krajska nemocnice Zlin
  • Hungary
      • Budapest, Hungary
        • National Institute of Oncology
      • Budapest, Hungary
        • Szent Imre Korhaz Onkologia
      • Budapest, Hungary
        • Szent László Kórház, Onkológia
      • Esztergom, Hungary
        • Vaszary Kolos Kórház
      • Gyor, Hungary
        • Petz Aladar County Hospital, Department of Oncology
      • Rakoczi, Hungary
        • Baranya megyei Korhaz Onkologial osztaly
  • India
      • Bangalore, India, 560027
        • Bangalore Institute of Oncology
      • Bangalore, India
        • Curie Centre of Oncology
      • Jaipur, India, 302004
        • Radhakrishan Birla Cancer Centre
      • Mumbai, India, 400026
        • Jaslok Hospital and Research Centre
      • New Delhi, India
        • Sir Ganga Ram Hospital
  • Mexico
      • Chihuahua, Mexico, 31000
        • Centro Estatal de Cancerología
      • Chihuahua, Mexico, 31000
        • Hospital Clínica del Parque
      • Metepec, Mexico, 52410
        • Centro Medico ISSEMYM
      • Mexicali, Mexico, 21100
        • Hospital general "5 de Diciembre" ISSSTE
      • Mexicali, Mexico, 21100
        • Hospital Regional de Especialidades No. 30 IMSS
      • Mexico, DF, Mexico, 06720
        • Hospital de Oncologia Centro Medico
      • Mexico, DF, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45200
        • Hospital Universitario "Dr. Angel Leano"
    • NL
      • Monterrey, NL, Mexico, 64000
        • Hospital y Clinica OCA S.A. de C.V.
    • SLP
      • San Luis Potosi, SLP, Mexico, 78240
        • Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
    • Yucatan
      • Merida, Yucatan, Mexico, 97219
        • Hospital regional ISSSTE "Merida"
  • Romania
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Bucharest, Romania
        • Trestioreanu Institute of Oncology
      • Cluj-Napoca, Romania
        • "I. Chiricuta" Institute of Oncology
      • Craiova, Romania, 1100
        • Craiova Emergency Clinical County Hospital
      • Timisoara, Romania
        • Timisoara City Hospital
  • Russian Federation
      • Cheliabinsk, Russian Federation, 454087
        • Cheliabinsk Regional Oncology Center
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Oncology Center
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar City Oncology Center
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
      • Moscow, Russian Federation, 121356
        • Central Clinical Hospital of the presidentof the Russian Federation
      • Moscow, Russian Federation, 125284
        • Hertzen Research Institute of Oncology
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital of the Ministru of Transport n.a. Semashko
      • Orenburg, Russian Federation, 460021
        • Orenburg, Regional Oncology Center
      • Samara, Russian Federation, 443066
        • Samara Oncology Center
      • St. Petersburg, Russian Federation, 189646
        • St. Petersburg, Central Research Institute of Radiology
      • St. Petersburg, Russian Federation, 193015
        • Medical Academy of Postgraduate Education
      • St. Petersburg, Russian Federation
        • St. Petersburg Oncology Center
      • St.Petersburg, Russian Federation, 195065
        • Mechnikov State Medical Academy
      • Voronezh, Russian Federation, 394000
        • Voronezh Regional Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Oncology Center
    • Kaluzhskaya Region
      • Obninsk, Kaluzhskaya Region, Russian Federation, 249020
        • Institute of Medical Radiology, Russian Academy of Medical Science
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49102
        • Dnepropetrovsk City Clinical Hospital
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center
      • Kharkov, Ukraine, 61070
        • State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
      • Kiev, Ukraine, 03022
        • Institute of Oncology under the Academy of Medical Sciences of Ukraine
      • Kiev, Ukraine, 03039
        • Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
      • Krivoy Rog, Ukraine, 50048
        • Krivoy Rog City Oncology Center
      • Lugansk, Ukraine, 91047
        • Lugansk Regional Clinical Oncological Center
      • Nikolaev, Ukraine, 54044
        • Nikolaev Regional Oncology Centre
      • Odessa, Ukraine, 65025
        • Odessa regional clinical Hospital
      • Vinnitsa, Ukraine, 21029
        • Vinnitsa Regional Clinical Oncology Center
      • Zaporozhye, Ukraine, 69096
        • Zaporozhye Medical Academy of Postgraduate Education
      • Zhitomir, Ukraine, 10002
        • Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Los Angeles, California, United States, 90057
        • Augusta Oncology Associates
    • Colorado
      • Denver, Colorado, United States, 80210
        • Mile High Oncology
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology - Hematology Associates
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Palm Beach Institute of Hematology and Oncology
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Hematology/Oncology of the North Shore
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Medical Oncology/Hem
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Oncology
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Comprehensive Cancer Care Clinic
      • Rolla, Missouri, United States, 65401
        • Bond Clinic
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Office of Clinical Trials
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Vita Hematology Oncology PC
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • The Family Cancer Center , PLLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment
      • Fort Worth, Texas, United States, 76104
        • JPS Center for Cancer Care
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Association
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
  • Metastatic pancreatic cancer
  • Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer
  • Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
  • Recovered from reversible toxicities of prior therapy
  • Karnofsky performance status ≥70
  • All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion Criteria:

  • More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
  • Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start
  • Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
  • Active clinically significant infection requiring antibiotics
  • Known HIV positive or active hepatitis B or C
  • Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
  • No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
  • Major surgery within 3 weeks of the start of study treatment, without complete recovery
  • Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall Survival

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Objective tumor response rate
Pain Intensity
Duration of objective tumor response rate
6 month and 12 month survival
Serum CA 19-9
Performance Status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Threshold Pharmaceuticals

Collaborators

PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Estimate)

April 30, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-CR-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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