A Phase I/II study of GTI-2040 and capecitabine in patients with renal cell carcinoma View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2007-06-14

AUTHORS

Walter M. Stadler, Apurva A. Desai, David I. Quinn, Ronald Bukowski, Bernard Poiesz, Carl G. Kardinal, Nancy Lewis, Alex Makalinao, Peter Murray, Frank M. Torti

ABSTRACT

BackgroundFluoropyrimidine based therapy has modest activity in patients with metastatic renal carcinoma and inhibition of ribonucleotide reductase is synergistic in model systems. GTI-2040 is a 20-mer phosphorothioate oligonucleotide complimentary to the R2 component of ribonucleotide reductase that has activity in renal cancer models.MethodsMetastatic renal carcinoma patients without prior fluoropyrimidine therapy and normal organ function were treated with oral capecitabine 880 mg/m2 twice daily along with continuous infusion GTI-2040 starting at 148 mg/m2/day for 21 days, for each 28-day cycle. After completion of the phase I portion, the phase II study portion sought to rule out a null hypothesized 10% response rate versus an alternative 25% response rate utilizing α and β errors of 0.05 and 0.2, respectively. GTI-2040 pharmacokinetics and effects on ribonucleotide reductase expression in peripheral mononuclear cells were evaluated in a subset of patients.ResultsBased on one dose limiting toxicity in nine patients in the phase I portion, the phase II portion was conducted using the previously recommended 185 mg/m2/day dose of GTI-2040. Twenty-six patients were enrolled in the phase II portion to obtain 18 fully evaluable for response. Only one patient, treated at a GTI 2040 dose of 185 mg/m2/day in the phase I portion of the protocol, responded. Toxicities and GTI-2040 pharmacokinetics were consistent with previously reported results. R2 expression in peripheral mononuclear cells was too variable for accurate interpretation.ConclusionFurther study of GTI-2040 and capecitabine in metastatic renal cancer at this dose and schedule is not indicated. Further study is necessary to determine whether lack of activity is due to inadequate target inhibition or inadequate effect of appropriate targeting. More... »

PAGES

689-694

References to SciGraph publications

Journal

TITLE

Cancer Chemotherapy and Pharmacology

ISSUE

4

VOLUME

61

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-007-0524-6

DOI

http://dx.doi.org/10.1007/s00280-007-0524-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1034419544

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/17569043


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