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Randomized Phase II Trial of Paclitaxel Plus Carboplatin Therapy Versus Irinotecan Plus Cisplatin Therapy as First-Line Chemotherapy for Clear Cell Adenocarcinoma of the Ovary: A JGOG Study
  1. Satoshi Takakura, MD, PhD*,
  2. Masashi Takano, MD, PhD,
  3. Fumiaki Takahashi, PhD,
  4. Toshiaki Saito, MD, PhD§,
  5. Daisuke Aoki, MD,
  6. Noriyuki Inaba, MD, PhD,
  7. Kiichiro Noda, MD, PhD#,
  8. Toru Sugiyama, MD, PhD**,
  9. Kazunori Ochiai, MD, PhD*,
  10. on behalf of the Japanese Gynecologic Oncology Group (JGOG)
  1. *Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo;
  2. Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa;
  3. Division of Biostatistics, School of Pharmaceutical Sciences, Kitasato University, Tokyo;
  4. §Gynecology Service, National Kyushu Cancer Center, Fukuoka;
  5. Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo;
  6. Department of Obstetrics and Gynecology, Faculty of Medicine, Dokkyo Medical University, Mibu;
  7. #Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osakasayama; and
  8. **Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.
  1. Address correspondence and reprint requests to Kazunori Ochiai, Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo105-8461, Japan. E-mail: kochiai{at}


Introduction: Paclitaxel plus carboplatin (TC) is generally considered to be the "gold standard" regimen for treatment of epithelial ovarian carcinomas. Little data are available, however, on the use of this regimen in patients with clear cell adenocarcinoma of the ovary (CCC). Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC. We compared these 2 combinations in patients with CCC.

Methods: Patients (n = 99) with CCC were randomly assigned to receive either 180 mg/m2 paclitaxel on day 1 plus AUC 6 mg/mL × minute carboplatin on day 1 every 21 days (TC arm) or 60 mg/m2 irinotecan hydrochloride on days 1, 8, 15 plus 60 mg/m2 cisplatin on day 1 every 28 days (CPT-P arm).

Results: Percentages of patients receiving the scheduled 6 cycles of chemotherapy in the TC and CPT-P arms were 70.8% and 72.0%, respectively. Although toxicity was well tolerated in both arms, the toxicity profile of each arm differed. Progression-free survival (PFS) showed no significant difference between the 2 treatment groups. Because there were more patients with large residual disease in the CPT-P arm, we performed a subset analysis by removing those patients, and then compared the PFS with that of patients without residual disease or with residual disease less than 2 cm. The PFS tended to be longer in the CPT-P group, although the difference was not statistically significant.

Conclusions: A phase III randomized trial is required to elucidate the effectiveness of CPT-P combination chemotherapy for CCC.

  • Clear cell adenocarcinoma
  • Ovarian cancer
  • Irinotecan hydrochloride
  • Cisplatin
  • Paclitaxel
  • Carboplatin

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  • Toru Sugiyama, MD, PhD, and Kazunori Ochiai, MD, PhD, contributed equally to this work.

  • An outline of this study was presented at the 45th Congress of the Japanese Society of Clinical Oncology (JSCO, Kyoto, Japan, 2007) by S. Takakura et al and at the 15th International Meeting of the European Society Gynecological Oncology (ESGO, Berlin, Germany, 2007) by M. Takano et al.