Phase II study of capecitabine, irinotecan, and celecoxib in advanced colorectal cancer

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Abstract
3766 Background: The cyclooxygenase-2 (COX-2) enzyme is overexpressed in the majority of colorectal cancers. Inhibition of the COX-2 enzyme can sensitize colorectal cancer cells to the apoptotic effects of chemotherapeutic agents and block angiogenesis. This phase II study was undertaken to determine the effects of adding celecoxib to capecitabine and irinotecan regimen. Methods: The primary objective was to estimate the objective response rate of patients with metastatic colorectal cancer treated with irinotecan, capecitabine, and celecoxib. Previously untreated patients, except for adjuvant therapy, with metastatic colorectal adenocarcinoma were eligible for this study. Patients received irinotecan 70 mg/m2 on days 1 and 8, and capecitabine 2,000 mg/m2/day from day 1 to 14 of a 21-day cycle. Celecoxib was administered at a dose 400 mg twice-daily starting day –7 until termination from study. Results: A total of 23 patients (median age 58 years) were enrolled on the study. Median performance status was 1. A total of 97 cycles (range 0–12) were administered. In an intention to treat analysis, objective response and stable disease were seen in 41% (90% CI; 0.24–0.60) and 27%, respectively. Objective response rate in the 17 patients evaluable for response was 53%(90% CI; 0.31–0.72). No treatment related deaths were observed. The only grade 3/4 toxicity was diarrhea (22%). Two patients developed grade 2 hand-foot syndrome and one patient developed grade 3 neutropenia. Only 1 patient was hospitalised for grade 4 diarrhea. Conclusion: Celecoxib can be safely administered in combination with irinotecan and capecitabine. The inclusion of celecoxib appears to significantly reduce the toxicity profile of this regimen, especially with respect to the hand-foot syndrome, myelosuppression and mucositis. These results suggest that this triple regimen has an optimum therapeutic index in metastatic colorectal cancer.

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