A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
NCT ID: NCT00040092
Last Updated: 2008-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Virulizin®
Eligibility Criteria
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Inclusion Criteria
* No previous systemic chemotherapy(unless given as a radiosensitizer).
* ECOG Performance Status 0-2
* Life expectancy equal to or greater than 12 weeks
* Adequate laboratory and organ functions
* Stabilizable pain (stable analgesic intake)
* No radiotherapy during 4 weeks prior to trial entry
* No evidence of ascites, pleural effusion or third space fluid accumulation
* Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy
18 Years
ALL
No
Sponsors
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Aptose Biosciences Inc.
INDUSTRY
References
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Ferdinandi ES, Braun DP, Liu C, Zee BC, Ely G. Virulizin(R) - A review of its antineoplastic activity. Expert Opin Investig Drugs. 1999 Oct;8(10):1721-1735. doi: 10.1517/13543784.8.10.1721.
Liu C, Ferdinandi ES, Ely G, Joshi SS. Virulizin-2gamma, a novel immunotherapeutic agent, in treatment of human pancreatic cancer xenografts. Int J Oncol. 2000 May;16(5):1015-20. doi: 10.3892/ijo.16.5.1015.
Warner E, Weinroth J, Chang S, MacDonald M, Strauss B. Phase II trial of Virulizin in patients with pancreatic cancer. Clin Invest Med. 1994 Feb;17(1):37-41.
Other Identifiers
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LOR/VIR/P03/002
Identifier Type: -
Identifier Source: org_study_id
NCT00045409
Identifier Type: -
Identifier Source: nct_alias
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