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Annals of Oncology 13:1819-1825, 2002
© 2002 European Society for Medical Oncology

Original Paper

Phase I study of rubitecan and gemcitabine in patients with advanced malignancies

P. M. Fracasso+, J. S. Rader, R. Govindan, T. J. Herzog, M. A. Arquette, A. Denes, D. G. Mutch, J. Picus, B. R. Tan, C. L. Fears, S. A. Goodner and S. L. Sun

Alvin J. Siteman Cancer Center, Departments of Medicine and Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO; and SuperGen, Inc., Dublin, CA, USA

Received 23 May 2002; revised 10 July 2002; accepted 9 August 2002

Background:

Rubitecan (9-nitrocamptothecin, 9-NC, OrathecinTM) and gemcitabine have single-agent activity in pancreatic and ovarian carcinoma. We conducted a phase I trial to evaluate the maximum tolerated dose (MTD) and toxicities of this combination in advanced malignancies.

Patients and methods:

Twenty-one patients with refractory or recurrent malignancies were enrolled in this dose escalation trial. Dose escalation proceeded from a starting level of rubitecan at 0.75 mg/m2/day administered orally on days 1–5 and 8–12 in combination with gemcitabine 1000 mg/m2 administered intravenously on days 1 and 8 of a 21-day cycle.

Results:

The MTD was defined as rubitecan 1 mg/m2 administered orally days 1–5 and 8–12, and gemcitabine 1000 mg/m2 administered intravenously over 30 min days 1 and 8, given every 21 days. Dose-limiting toxicity was myelosuppression including neutropenia and thrombocytopenia. Other side effects included diarrhea, nausea, vomiting and fatigue. Five patients with stable disease were observed among 18 evaluable patients.

Conclusions:

The recommended phase II dose is rubitecan 1 mg/m2 given orally on days 1–5 and 8–12 in combination with gemcitabine 1000 mg/m2 as a 30-min intravenous infusion on days 1 and 8 of a 21-day cycle.

Key words: gemcitabine, Gemzar®, 9-nitrocamptothecin, OrathecinTM, phase I, rubitecan


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