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

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Threshold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00099294
First received: December 10, 2004
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Glufosfamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • Overall Survival

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

Estimated Enrollment: 300
Study Start Date: September 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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))
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099294

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00099294     History of Changes
Other Study ID Numbers: TH-CR-302
Study First Received: December 10, 2004
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Threshold Pharmaceuticals:
Pancreas
Cancer
Pancreatic Adenocarcinoma
Metastatic
Glufosfamide

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Ifosfamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014