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Japanese Journal of Clinical Oncology 32:128-134 (2002)
© 2002 Foundation for Promotion of Cancer Research

A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer

Ritsu Yamamoto1, Shinichiro Minobe1, Masanori Kaneuchi1, Noriaki Sakuragi1, Seiichiro Fujimoto1, Yoshiaki Ishizaki2, Hiroka Domon3, Hitoshi Hareyama4, Chikara Sato5, Takahumi Fujino5, Isao Kawaguchi6, Tatsumi Yamaguchi7, Toshio Fujimoto8 and Ken Yoshiaki9,+

1 Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, 2 Kohnan Hospital, Sapporo, 3 Sapporo Kohsei Hospital, Sapporo, 4 Sapporo City Hospital, Sapporo, 5 Teine Keijinkai Hospital, Sapporo, 6 Obihiro Kohsei Hospital, Obihiro, 7 Kushiro Red Cross Hospital, Kushiro, 8 Hakodate National Hospital, Hakodate and 9 Asahikawa City Hospital, Asahikawa, Hokkaido, Japan

Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer.

Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m2. The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated.

Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m2 administration group, we chose 175 mg/m2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively.

Conclusion: Combination chemotherapy using paclitaxel 175 mg/m2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.

+ For reprints and all correspondence: Ritsu Yamamoto, Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Kita-15, Nishi-7, Kita-Ku, Sapporo 060-8638, Japan. E-mail: rityam@med.hokudai.ac.jp


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