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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099294
• Other study ID #: TH-CR-302
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: April 28, 2009
• Start date: September 2004
• Est. completion date: January 2007

Study information

• Verified date: April 2009
• Source: Threshold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Glufosfamide

Locations

Country	Name	City	State
Argentina	Hospital Alvarez	Buenos Aires
Argentina	Hospital Churruca - Visca	Buenos Aires
Argentina	Hospital Interzonal General de Agudos	Buenos Aires
Argentina	Hospital Posadas	Buenos Aires
Argentina	Hospital Udaondo	Buenos Aires
Argentina	Instituto Medico Alexander Fleming	Buenos Aires
Argentina	Policlinica Privada Instituto de Medicina Nuclear	Buenos Aires
Argentina	Instituto CAICI	Santa Fe
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos
Brazil	Hospital Luxemburgo	Belo Horizonte
Brazil	Hospital Vera Cruz - Clinica de Oncologia	Belo Horizonte
Brazil	Hospital de Clínicas da UFPR	Curitiba
Brazil	Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica	Goiania
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre
Brazil	Instituto Nacional do Cancer - INCA	Rio de Janeiro
Brazil	Clinica de Oncologia Medica S/C Ltda	Sao Paulo
Brazil	Hospital do Cancer - AC Camargo	Sao Paulo
Brazil	Grupo Paulista Oncologia Integrada	São Paulo
Bulgaria	Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University	Pleven
Bulgaria	First Internal Department Plovdiv Regional Oncology Center with In-patient Department	Plovdiv
Bulgaria	Chemotherapy Clinic Queen Joanna General Hospital	Sofia
Bulgaria	Chemotherapy Clinic Specialized Oncology Hospital	Sofia
Bulgaria	Department of Chemotherapy Sofia Regional Oncology Center	Sofia
Bulgaria	Haematology and Oncology Clinic Military Medical Academy	Sofia
Bulgaria	Department of Chemotherapy Veliko Tarnovo Regional Oncology Center	Tarnovo
Bulgaria	Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center	Varna
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
Hungary	National Institute of Oncology	Budapest
Hungary	Szent Imre Korhaz Onkologia	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
India	Bangalore Institute of Oncology	Bangalore
India	Curie Centre of Oncology	Bangalore
India	Radhakrishan Birla Cancer Centre	Jaipur
India	Jaslok Hospital and Research Centre	Mumbai
India	Sir Ganga Ram Hospital	New Delhi
Mexico	Centro Estatal de Cancerologia	Chihuahua
Mexico	Hospital Clinica del Parque	Chihuahua
Mexico	Hospital regional ISSSTE "Merida"	Merida	Yucatan
Mexico	Centro Medico ISSEMYM	Metepec
Mexico	Hospital general "5 de Diciembre" ISSSTE	Mexicali
Mexico	Hospital Regional de Especialidades No. 30 IMSS	Mexicali
Mexico	Hospital de Oncologia Centro Medico	Mexico, DF
Mexico	Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"	Mexico, DF
Mexico	Hospital y Clinica OCA S.A. De C.V.	Monterrey	NL
Mexico	Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.	San Luis Potosi	SLP
Mexico	Hospital Universitario "Dr. Angel Leano"	Zapopan	Jalisco
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	Timisoara City Hospital	Timisoara
Russian Federation	Cheliabinsk Regional Oncology Center	Cheliabinsk
Russian Federation	Irkutsk Regional Oncology Center	Irkutsk
Russian Federation	Clinical Oncology Center	Kazan
Russian Federation	Krasnodar City Oncology Center	Krasnodar
Russian Federation	Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy	Moscow
Russian Federation	Central Clinical Hospital of the Ministru of Transport n.a. Semashko	Moscow
Russian Federation	Central Clinical Hospital of the presidentof the Russian Federation	Moscow
Russian Federation	Hertzen Research Institute of Oncology	Moscow
Russian Federation	Institute of Medical Radiology, Russian Academy of Medical Science	Obninsk	Kaluzhskaya Region
Russian Federation	Orenburg, Regional Oncology Center	Orenburg
Russian Federation	Samara Oncology Center	Samara
Russian Federation	Medical Academy of Postgraduate Education	St. Petersburg
Russian Federation	St. Petersburg Oncology Center	St. Petersburg
Russian Federation	St. Petersburg, Central Research Institute of Radiology	St. Petersburg
Russian Federation	Mechnikov State Medical Academy	St.Petersburg
Russian Federation	Voronezh Regional Clinical Oncology Center	Voronezh
Russian Federation	Yaroslavl Regional Oncology Center	Yaroslavl
Ukraine	Dnepropetrovsk City Clinical Hospital	Dnepropetrovsk
Ukraine	Donetsk Regional Antitumor Center	Donetsk
Ukraine	State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center	Kharkov
Ukraine	Institute of Oncology under the Academy of Medical Sciences of Ukraine	Kiev
Ukraine	Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery	Kiev
Ukraine	Krivoy Rog City Oncology Center	Krivoy Rog
Ukraine	Lugansk Regional Clinical Oncological Center	Lugansk
Ukraine	Nikolaev Regional Oncology Centre	Nikolaev
Ukraine	Odessa Regional Clinical Hospital	Odessa
Ukraine	Vinnitsa Regional Clinical Oncology Center	Vinnitsa
Ukraine	Zaporozhye Medical Academy of Postgraduate Education	Zaporozhye
Ukraine	Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky	Zhitomir
United States	Cancer Outreach Association	Abingdon	Virginia
United States	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico
United States	Vita Hematology Oncology PC	Bethlehem	Pennsylvania
United States	Deaconess Billings Clinic	Billings	Montana
United States	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida
United States	The Family Cancer Center , PLLC	Collierville	Tennessee
United States	Columbia Comprehensive Cancer Care Clinic	Columbia	Missouri
United States	Center for Oncology Research and Treatment	Dallas	Texas
United States	Mile High Oncology	Denver	Colorado
United States	Fort Wayne Medical Oncology/Hem	Fort Wayne	Indiana
United States	JPS Center for Cancer Care	Fort Worth	Texas
United States	Hattiesburg Clinic Oncology	Hattiesburg	Mississippi
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Augusta Oncology Associates	Los Angeles	California
United States	Kenmar Research Institute	Los Angeles	California
United States	Norton Healthcare Center	Louisville	Kentucky
United States	Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Northern Utah Associates	Ogden	Utah
United States	Office of Clinical Trials	Paramus	New Jersey
United States	Bond Clinic	Rolla	Missouri
United States	Hematology/Oncology of the North Shore	Skokie	Illinois
United States	Northwestern Connecticut Oncology - Hematology Associates	Torrington	Connecticut
United States	Hanover Medical Specialists	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Threshold Pharmaceuticals	PPD

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Czech Republic,  Hungary,  India,  Mexico,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival
Secondary	Objective tumor response rate
Secondary	Duration of objective tumor response rate
Secondary	Progression-free survival
Secondary	6 month and 12 month survival
Secondary	Serum CA 19-9
Secondary	Pain Intensity
Secondary	Performance Status

External Links

•   Threshold Pharmaceuticals Website