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Annals of Oncology Advance Access published online on April 26, 2006
Annals of Oncology, doi:10.1093/annonc/mdl081
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© 2006 European Society for Medical Oncology
Received December 23, 2005
Revised March 7, 2006
Accepted March 8, 2006

original article

Gemcitabine plus CI-994 offers no advantage over gemcitabine alone in the treatment of patients with advanced pancreatic cancer: results of a phase II randomized, double-blind, placebo-controlled, multicenter study

D. A. Richards 1 *, K. A. Boehm 1, D. M. Waterhouse 2, D. J. Wagener 3, S. S. Krishnamurthi 4, A. Rosemurgy 5, W. Grove 6, K. Macdonald 6, S. Gulyas 6, M. Clark 6, and K. D. Dasse 6

1 US Oncology Research, Inc., Houston, TX
2 Oncology/Hematology Care Inc, Cincinnati, OH, USA
3 Academish Ziekenhuis Nijmegen St. Raboud, Nijmegen, the Netherlands
4 University Hospitals of Cleveland, Ireland Cancer Center, Cleveland, OH
5 University of South Florida, Tampa FL
6 Pfizer Global Research and Development, Ann Arbor, MI, USA

* To whom correspondence should be addressed.
D. A. Richards, E-mail: Donald.Richards{at}USOncology.com


  Abstract

Background: CI-994, an oral histone deacetylase inhibitor, has antineoplastic activity and synergism with gemcitabine preclinically. This randomized phase II trial explored whether CI-994 plus gemcitabine improves overall survival, objective response, duration of response, time to treatment failure and change in quality of life (QoL) or pain compared with gemcitabine alone.

Patients and methods: A total of 174 patients received CG (CI-994 6 mg/m2/day days 1-21 plus gemcitabine 1000 mg/m2 days 1, 8 and 15 each 28-day cycle) or PG (placebo plus gemcitabine 1000 mg/m2 days 1, 8 and 15 of each 28-day cycle days 1-21).

Results: Median survival was 194 days (CG) versus 214 days (PG) (P = 0.908). The objective response rate with CG was 12% versus 14% with PG when investigator-assessed and 1% versus 6%, respectively, when assessed centrally. Time to treatment failure did not differ between the two arms (P = 0.304). QoL scores at 2 months were worse with CG than with PG. Pain response rates were similar between the two groups. There was an increased incidence of neutropenia and thrombocytopenia with CG.

Conclusions: Adding CI-994 to gemcitabine in advanced pancreatic carcinoma does not improve overall survival, response rate or time to progression; CG produced decreased QoL and increased hematological toxicity and appears inferior to single-agent gemcitabine.

Keywords: gemcitabine; histone deacetylation inhibitor; metastatic disease; pain; pancreatic cancer; placebo; quality of life.
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