Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide
Eligibility 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))
Sites / Locations
- Augusta Oncology Associates
- Kenmar Research Institute
- Mile High Oncology
- Northwestern Connecticut Oncology - Hematology Associates
- Palm Beach Institute of Hematology and Oncology
- Hematology/Oncology of the North Shore
- Fort Wayne Medical Oncology/Hem
- Norton Healthcare Center
- West Michigan Cancer Center
- Hattiesburg Clinic Oncology
- Columbia Comprehensive Cancer Care Clinic
- Bond Clinic
- Deaconess Billings Clinic
- Office of Clinical Trials
- New Mexico Oncology Hematology Consultants
- Hanover Medical Specialists
- Vita Hematology Oncology PC
- The Family Cancer Center , PLLC
- Center for Oncology Research and Treatment
- JPS Center for Cancer Care
- Northern Utah Associates
- Cancer Outreach Association
- Marshfield Clinic Research Foundation
- Hospital Interzonal General de Agudos
- Hospital Posadas
- Policlinica Privada Instituto de Medicina Nuclear
- Hospital Udaondo
- Hospital Alvarez
- Hospital Churruca - Visca
- Instituto Medico Alexander Fleming
- Instituto CAICI
- Fundacao Pio XII - Hospital de Cancer de Barretos
- Fundação Pio XII - Hospital de Câncer de Barretos
- Hospital Vera Cruz - Clinica de Oncologia
- Hospital Luxemburgo
- Hospital de Clínicas da UFPR
- Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
- Hospital Nossa Senhora da Conceicao
- Instituto Nacional do Cancer - INCA
- Clinica de Oncologia Medica S/C Ltda
- Hospital do Cancer - AC Camargo
- Grupo Paulista Oncologia Integrada
- Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
- First Internal Department Plovdiv Regional Oncology Center with In-patient Department
- Department of Chemotherapy Sofia Regional Oncology Center
- Chemotherapy Clinic Queen Joanna General Hospital
- Haematology and Oncology Clinic Military Medical Academy
- Chemotherapy Clinic Specialized Oncology Hospital
- Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
- Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
- Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
- Masarykuv onkologicky Ustav
- Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
- Onkologicka Klinika, Fakultni nemocnice Olomouc
- Onkologicke Oddeleni, Batova krajska nemocnice Zlin
- National Institute of Oncology
- Szent Imre Korhaz Onkologia
- Szent László Kórház, Onkológia
- Vaszary Kolos Korhaz
- Petz Aladar County Hospital, Department of Oncology
- Baranya megyei Korhaz Onkologial osztaly
- Bangalore Institute of Oncology
- Curie Centre of Oncology
- Radhakrishan Birla Cancer Centre
- Jaslok Hospital and Research Centre
- Sir Ganga Ram Hospital
- Hospital Universitario "Dr. Angel Leano"
- Hospital y Clinica OCA S.A. De C.V.
- Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
- Hospital regional ISSSTE "Merida"
- Centro Estatal de Cancerologia
- Hospital Clinica del Parque
- Centro Medico ISSEMYM
- Hospital general "5 de Diciembre" ISSSTE
- Hospital Regional de Especialidades No. 30 IMSS
- Hospital de Oncologia Centro Medico
- Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
- Fundeni Clinical Institute
- Trestioreanu Institute of Oncology
- "I. Chiricuta" Institute of Oncology
- Craiova Emergency Clinical County Hospital
- Timisoara City Hospital
- Institute of Medical Radiology, Russian Academy of Medical Science
- Cheliabinsk Regional Oncology Center
- Irkutsk Regional Oncology Center
- Clinical Oncology Center
- Krasnodar City Oncology Center
- Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
- Central Clinical Hospital of the presidentof the Russian Federation
- Hertzen Research Institute of Oncology
- Central Clinical Hospital of the Ministru of Transport n.a. Semashko
- Orenburg, Regional Oncology Center
- Samara Oncology Center
- St. Petersburg, Central Research Institute of Radiology
- Medical Academy of Postgraduate Education
- St. Petersburg Oncology Center
- Mechnikov State Medical Academy
- Voronezh Regional Clinical Oncology Center
- Yaroslavl Regional Oncology Center
- Dnepropetrovsk City Clinical Hospital
- Donetsk Regional Antitumor Center
- State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
- Institute of Oncology under the Academy of Medical Sciences of Ukraine
- Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
- Krivoy Rog City Oncology Center
- Lugansk Regional Clinical Oncological Center
- Nikolaev Regional Oncology Centre
- Odessa Regional Clinical Hospital
- Vinnitsa Regional Clinical Oncology Center
- Zaporozhye Medical Academy of Postgraduate Education
- Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky