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Annals of Oncology 13:1674-1680, 2002
© 2002 European Society for Medical Oncology

Original Paper

A phase I study of sequential irinotecan and 5-fluorouracil/leucovorin

R. M. Goldberg1, S. H. Kaufmann1, P. Atherton1, J. A. Sloan1, A. A. Adjei1, H. C. Pitot1, S. R. Alberts1, J. Rubin1, L. L. Miller2 and C. Erlichman1,+

1 Department of Oncology, Mayo Clinic, Rochester, MN; 2 Pharmacia Corporation, Peapack, NJ, USA

Received 16 November 2001; revised 21 February 2002; accepted 27 March 2002

Background:

Irinotecan (CPT-11) and 5-fluorouracil (5-FU)/leucovorin are active agents in colorectal cancer. A sequence-dependent synergism of SN-38 followed by 5-FU/leucovorin in vitro led us to conduct a phase I trial of CPT-11 followed by 5-FU/leucovorin to determine the maximum tolerated dose (MTD) and toxicities of this regimen and to obtain preliminary indications of its activity in patients with advanced solid tumors.

Patients and methods:

Fifty-six patients were enrolled in sequential cohorts to receive escalating doses of CPT-11 (90 min infusion) on day 1, followed by leucovorin 20 mg/m2 (intravenous push) and 5-FU (90 min infusion) on days 2–5 of each 21-day cycle.

Results:

A total of 347 treatment cycles (median 4, range 1–25) were administered. Dose-limiting toxicities were diarrhea, neutropenia and fatigue. Nine patients with colorectal cancer and one with gastric cancer had partial or minor responses. Eight of the 10 had prior chemotherapy.

Conclusions:

CPT-11 and 5-FU/leucovorin, as constituents of this novel mechanism-based schedule, have promising activity in patients who have received prior chemotherapy. The recommended phase II/III starting doses are CPT-11 275 mg/m2 over 90 min on day 1, and 5-FU 400 mg/m2 plus leucovorin 20 mg/m2 on days 2–5 every 21 days. This combination can be administered safely to this schedule if there is strict adherence to the 90 min infusion time for both CPT-11 and 5-FU.

Key words: 5-fluourouracil, irinotecan, leucovorin, phase I


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