Cancer Chemotherapy and Pharmacology

, Volume 60, Issue 1, pp 135–141

A phase II trial of continuous low-dose oral cyclophosphamide and celecoxib in patients with renal cell carcinoma

  • Monika K. Krzyzanowska
  • Ian F. Tannock
  • Gina Lockwood
  • Jennifer Knox
  • Malcolm Moore
  • Georg A. Bjarnason
Clinical Trial Report

DOI: 10.1007/s00280-006-0347-x

Cite this article as:
Krzyzanowska, M.K., Tannock, I.F., Lockwood, G. et al. Cancer Chemother Pharmacol (2007) 60: 135. doi:10.1007/s00280-006-0347-x

Abstract

Purpose

The lack of effective systemic therapies for patients with advanced renal cell carcinoma (RCC) has stimulated interest in evaluating novel treatment strategies for this disease.

Methods

This was a two-institution, two-stage, phase II trial of continuous low-dose oral cyclophosphamide (50 mg daily) in combination with celecoxib (400 mg twice daily) in patients with progressive, locally advanced or metastatic RCC. The primary endpoint was disease control rate (DCR) defined as the number of patients with complete (CR) or partial response (PR) or prolonged (≥6 months) stable disease (SD). Secondary endpoints included time to progression and toxicity.

Results

Between May 2001 and January 2003, 36 patients were enrolled onto the trial of which 32 were evaluable for response. One patient had a PR and three others had SD for longer than 6 months (DCR 12.5%, 95% CI 3.5–29.0%). The median progression free survival was 3.5 months (95% CI, 1.9–4.1 months) and the median overall survival was 14.5 months (95% CI, 8.4–20.8 months). One patient experienced grade five gastrointestinal bleeding. Otherwise, the treatment was well tolerated.

Conclusions

Although generally well tolerated, continuous therapy with low-dose cyclophosphamide and celecoxib had limited activity in RCC.

Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Monika K. Krzyzanowska
    • 1
  • Ian F. Tannock
    • 1
  • Gina Lockwood
    • 2
  • Jennifer Knox
    • 1
  • Malcolm Moore
    • 1
  • Georg A. Bjarnason
    • 3
  1. 1.Department of Medical Oncology and HematologyPrincess Margaret HospitalTorontoCanada
  2. 2.Department of BiostatisticsPrincess Margaret HospitalTorontoCanada
  3. 3.Department of Medical Oncology and HematologyToronto-Sunnybrook Regional Cancer CenterTorontoCanada