Abstract
Purpose:
To evaluate the maximum tolerated dose, safety profile, pharmacokinetics, and pharmacodynamics of pegaspargase (PEG-ASP) in combination with gemcitabine in patients with advanced metastatic solid tumors and lymphoma.
Methods:
We conducted a multicenter, open label, nonrandomized, Phase 1 dose escalation study designed to evaluate up to 10 cohorts of patients with advanced or metastatic solid tumors and lymphoma. Seventeen patients were treated with of PEG-ASP in combination with gemcitabine.
Results:
The study was terminated early because the doses for PEG-ASP suggested for de-escalation were predicted not to provide desired sustained asparaginase concentrations based on the analysis of treated patients.
Keywords:
Gemcitabine; Lymphoma; Metastatic solid tumors; Pegaspargase; Phase 1.
Publication types
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Clinical Trial, Phase I
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols
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Asparaginase / administration & dosage*
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Asparaginase / antagonists & inhibitors
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Asparaginase / pharmacokinetics
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Deoxycytidine / administration & dosage
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives*
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Deoxycytidine / pharmacokinetics
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Dose-Response Relationship, Drug
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Female
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Gemcitabine
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Humans
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Lymphoma / drug therapy*
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Lymphoma / pathology
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Male
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Maximum Tolerated Dose
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Middle Aged
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Neoplasm Metastasis
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Neoplasms / drug therapy*
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Neoplasms / pathology
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Polyethylene Glycols / administration & dosage*
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Polyethylene Glycols / pharmacokinetics
Substances
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Deoxycytidine
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Polyethylene Glycols
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pegaspargase
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Asparaginase
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Gemcitabine