Michael, M., Brittain, M., Nagai, J., Feld, R., Hedley, D., Oza, A., … Moore, M.J. (2004). Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. Journal of Clinical Oncology, 22(21), 4410–4417.doi: 10.1200/JCO.2004.11.125
In cycle 1, 28 patients received irinotecan plus 1,000 mg oral-activated charcoal (AC) plus 25 ml water the evening before irinotecan and then three times per day for 48 hours after, on an empty stomach. In cycle 2, 24 patients received irinotecan without AC.
This study reported on 52 patients with advanced colorectal cancer receiving 125 mg/m2 irinotecan weekly for four weeks with two weeks of rest.
This was a prospective, nonrandomized trial; patients served as their own controls.
Any statistical comparison in the efficacy parameters defined in the trial would be associated with large confidence intervals.
This was an exploratory trial with small patient numbers; results are hypothesis-generating and require additional confirmation in a larger study.