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Annals of Oncology 14:1121-1125, 2003
© 2003 European Society for Medical Oncology

Original Paper

Multicenter phase II trial evaluating a three-weekly schedule of irinotecan plus raltitrexed in patients with 5-fluorouracil-refractory advanced colorectal cancer

J. Aparicio1,+, J. M. Vicent2, I. Maestu3, S. Garcerá4, I. Busquier5, C. Bosch6, C. Llorca7, R. Díaz1, C. Fernández-Martos8 and A. Galán9

1 Medical Oncology, Hospital Universitario La Fe; 2 Medical Oncology, Hospital General Universitario, Valencia; 3 Medical Oncology, Hospital Virgen de los Lirios, Alcoy; 4 Medical Oncology, Hospital La Ribera, Alzira; 5 Medical Oncology, Hospital Provincial, Castellón; 6 Medical Oncology, Hospital Doctor Peset, Valencia; 7 Medical Oncology, Hospital General, Elda; 8 Medical Oncology, Instituto Valenciano de Oncología; 9 Hospital de Sagunto, Valencia, Spain

Received 13 November 2002; revised 16 January 2003; accepted 19 February 2003

Background:

Irinotecan (CPT-11) and raltitrexed are active against advanced colorectal cancer (ACC), act through different mechanisms, and have only partially overlapping toxicity profiles. Phase I studies have shown that single-agent full doses of both drugs can be safely combined. The aim of this multicenter study was to assess the efficacy and toxicity of the combination in patients with 5-fluorouracil (5-FU)-refractory ACC.

Patients and methods:

Between October 1999 and December 2000, 52 patients (31 males, 21 females) with a median age of 62 years (range 39–75) were included and received CPT-11 (350 mg/m2 as a 60-min infusion) plus raltitrexed (3 mg/m2 as a 15-min infusion, 1 h after CPT-11), with courses repeated every 21 days. Objective response was assessed after every three courses, and treatment maintained until tumor progression or unacceptable toxicity.

Results:

A total of 313 cycles were administered, with a median of six cycles per patient (range 1–14). Seven patients (13.5%) achieved a partial response and one a complete response (1.9%), for an overall intention-to-treat response rate of 15.4% (95% confidence interval 6.1% to 27.2%). The incidence of grade 3/4 toxicity was 23.1% for diarrhea, 21.2% for asthenia, 17.3% for neutropenia, 13.4% for emesis and 7.7% for infection. There were no treatment-related deaths. With a median follow-up of 20 months, median survival was 11.9 months and median time to progression was 4.6 months.

Conclusions:

CPT-11 plus raltitrexed is active in patients with 5-FU-refractory ACC, at the expense of moderate toxicity.

Key words: irinotecan, metastatic colorectal cancer, phase II, raltitrexed, second line


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