, Volume 60, Issue 1, pp 135-141
Date: 29 Sep 2006

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

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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.