Clinical trial NCT00099294: Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Pancreas
Cancer
Pancreatic Adenocarcinoma
Metastatic
Glufosfamide
Lead sponsor: Threshold Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2004-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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))

Primary outcomes:
measure: Overall Survival
Secondary outcomes:
measure: Objective tumor response rate
measure: Duration of objective tumor response rate
measure: Progression-free survival
measure: 6 month and 12 month survival
measure: Serum CA 19-9
measure: Pain Intensity
measure: Performance Status
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Augusta Oncology Associates
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Denver
country: United States
facility: Mile High Oncology
state: Colorado
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology - Hematology Associates
state: Connecticut
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Skokie
country: United States
facility: Hematology/Oncology of the North Shore
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology/Hem
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare Center
state: Kentucky
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Oncology
state: Mississippi
city: Columbia
country: United States
facility: Columbia Comprehensive Cancer Care Clinic
state: Missouri
city: Rolla
country: United States
facility: Bond Clinic
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic
state: Montana
city: Paramus
country: United States
facility: Office of Clinical Trials
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: Wilmington
country: United States
facility: Hanover Medical Specialists
state: North Carolina
city: Bethlehem
country: United States
facility: Vita Hematology Oncology PC
state: Pennsylvania
city: Collierville
country: United States
facility: The Family Cancer Center , PLLC
state: Tennessee
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment
state: Texas
city: Fort Worth
country: United States
facility: JPS Center for Cancer Care
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Abingdon
country: United States
facility: Cancer Outreach Association
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Interzonal General de Agudos
city: Buenos Aires
country: Argentina
facility: Hospital Posadas
city: Buenos Aires
country: Argentina
facility: Policlinica Privada Instituto de Medicina Nuclear
city: Buenos Aires
country: Argentina
facility: Hospital Udaondo
city: Buenos Aires
country: Argentina
facility: Hospital Alvarez
city: Buenos Aires
country: Argentina
facility: Hospital Churruca - Visca
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming
city: Santa Fe
country: Argentina
facility: Instituto CAICI
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz - Clinica de Oncologia
city: Belo Horizonte
country: Brazil
facility: Hospital Luxemburgo
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da UFPR
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer - INCA
city: Sao Paulo
country: Brazil
facility: Clinica de Oncologia Medica S/C Ltda
city: Sao Paulo
country: Brazil
facility: Hospital do Cancer - AC Camargo
city: São Paulo
country: Brazil
facility: Grupo Paulista Oncologia Integrada
city: Pleven
country: Bulgaria
facility: Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
city: Plovdiv
country: Bulgaria
facility: First Internal Department Plovdiv Regional Oncology Center with In-patient Department
city: Sofia
country: Bulgaria
facility: Department of Chemotherapy Sofia Regional Oncology Center
city: Sofia
country: Bulgaria
facility: Chemotherapy Clinic Queen Joanna General Hospital
city: Sofia
country: Bulgaria
facility: Haematology and Oncology Clinic Military Medical Academy
city: Sofia
country: Bulgaria
facility: Chemotherapy Clinic Specialized Oncology Hospital
city: Tarnovo
country: Bulgaria
facility: Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
city: Varna
country: Bulgaria
facility: Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
city: Brno
country: Czech Republic
facility: Masarykuv onkologicky Ustav
city: Kyjevska
country: Czech Republic
facility: Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
city: Olomouc
country: Czech Republic
facility: Onkologicka Klinika, Fakultni nemocnice Olomouc
city: Zlin
country: Czech Republic
facility: Onkologicke Oddeleni, Batova krajska nemocnice Zlin
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Budapest
country: Hungary
facility: Szent Imre Korhaz Onkologia
city: Budapest
country: Hungary
facility: Szent László Kórház, Onkológia
city: Esztergom
country: Hungary
facility: Vaszary Kolos Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar County Hospital, Department of Oncology
city: Rakoczi
country: Hungary
facility: Baranya megyei Korhaz Onkologial osztaly
city: Bangalore
country: India
facility: Bangalore Institute of Oncology
city: Bangalore
country: India
facility: Curie Centre of Oncology
city: Jaipur
country: India
facility: Radhakrishan Birla Cancer Centre
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Zapopan
country: Mexico
facility: Hospital Universitario "Dr. Angel Leano"
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital y Clinica OCA S.A. De C.V.
state: NL
city: San Luis Potosi
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
state: SLP
city: Merida
country: Mexico
facility: Hospital regional ISSSTE "Merida"
state: Yucatan
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia
city: Chihuahua
country: Mexico
facility: Hospital Clinica del Parque
city: Metepec
country: Mexico
facility: Centro Medico ISSEMYM
city: Mexicali
country: Mexico
facility: Hospital general "5 de Diciembre" ISSSTE
city: Mexicali
country: Mexico
facility: Hospital Regional de Especialidades No. 30 IMSS
city: Mexico, DF
country: Mexico
facility: Hospital de Oncologia Centro Medico
city: Mexico, DF
country: Mexico
facility: Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Trestioreanu Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: "I. Chiricuta" Institute of Oncology
city: Craiova
country: Romania
facility: Craiova Emergency Clinical County Hospital
city: Timisoara
country: Romania
facility: Timisoara City Hospital
city: Obninsk
country: Russian Federation
facility: Institute of Medical Radiology, Russian Academy of Medical Science
state: Kaluzhskaya Region
city: Cheliabinsk
country: Russian Federation
facility: Cheliabinsk Regional Oncology Center
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Center
city: Kazan
country: Russian Federation
facility: Clinical Oncology Center
city: Krasnodar
country: Russian Federation
facility: Krasnodar City Oncology Center
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the presidentof the Russian Federation
city: Moscow
country: Russian Federation
facility: Hertzen Research Institute of Oncology
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Ministru of Transport n.a. Semashko
city: Orenburg
country: Russian Federation
facility: Orenburg, Regional Oncology Center
city: Samara
country: Russian Federation
facility: Samara Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg, Central Research Institute of Radiology
city: St. Petersburg
country: Russian Federation
facility: Medical Academy of Postgraduate Education
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Oncology Center
city: St.Petersburg
country: Russian Federation
facility: Mechnikov State Medical Academy
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Oncology Center
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Oncology Center
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Clinical Hospital
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Center
city: Kharkov
country: Ukraine
facility: State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
city: Kiev
country: Ukraine
facility: Institute of Oncology under the Academy of Medical Sciences of Ukraine
city: Kiev
country: Ukraine
facility: Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
city: Krivoy Rog
country: Ukraine
facility: Krivoy Rog City Oncology Center
city: Lugansk
country: Ukraine
facility: Lugansk Regional Clinical Oncological Center
city: Nikolaev
country: Ukraine
facility: Nikolaev Regional Oncology Centre
city: Odessa
country: Ukraine
facility: Odessa Regional Clinical Hospital
city: Vinnitsa
country: Ukraine
facility: Vinnitsa Regional Clinical Oncology Center
city: Zaporozhye
country: Ukraine
facility: Zaporozhye Medical Academy of Postgraduate Education
city: Zhitomir
country: Ukraine
facility: Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky
Study officials:
References: