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Japanese Journal of Clinical Oncology 31:275-278 (2001)
© 2001 Foundation for Promotion of Cancer Research

Phase II Trial of Outpatient Schedule of Paclitaxel in Patients with Previously Untreated Metastatic, Measurable Adenocarcinoma of the Stomach

Agustin A. Garcia, Cynthia G. Leichman, Heinz Josef Lenz, Joaquina Baranda, Ramona Lujan, Yolee Casagrande and Lawrence Leichman+

Division of Medical Oncology, University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, CA, USA

Background: Chemotherapy represents the standard treatment for patients with metastatic stomach cancer. Conflicting results have been published regarding the activity of paclitaxel in this setting. Therefore, we developed a phase II study to evaluate an outpatient 3 h infusion of paclitaxel.

Methods: Patients with chemonaive metastatic stomach cancer received paclitaxel 210 mg/m2 every 3 weeks. Patients with esophageal cancer were not eligible.

Results: Twenty-one patients were enrolled. The median age was 55.5 years (range 37–81 years). Two partial responses were observed among the 18 patients evaluable for response and toxicity (response rate 11%, 95% CI: 2–33%). The median time to progression was 10.5 weeks and median survival 23 weeks. There was only one episode of grade IV neutropenia and no episodes of grade 3–4 non-hematological toxicity were observed.

Conclusion: Paclitaxel exhibited minimal activity in this patient population.

+ For reprints and all correspondence: Agustin A. Garcia, Division of Medical Oncology, University of Southern California/Norris Comprehensive Cancer Center, 1441 Eastlake Avenue, MS 34, Los Angeles, CA 90089-9173, USA. E-mail: aagarcia@hsc.usc.edu


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